Sponsored by: Associates of Cape Cod, bioMérieux, COPAN, CTL-MAT, METTLER TOLEDO, Microbiologics, Microgenetic
Pharmaceutical Microbiology UK
20th January to 21st January 2020,
Discovering Optimised Contamination Control and the Current Regulatory Landscape
SMi’s 9th Annual Conference
January 20 - 21, 2020 | London, United Kingdom
Pharmaceutical Microbiology as an industry is projected to see significant advancements in the next five years. This forecast is largely attributed to rapid microbiology testing, which has accounted for $3.5 billion last year, while projected to reach nearly double at $6 billion by 2025, and an estimated CAGR of 8.3% leading up to 2025.
At the very core of pharmaceutical microbiology is the accurate and reliable detection of microorganisms that would otherwise contaminate the pharmaceutical products manufactured. This demand for more rapid methods for detection and identification will be accompanied by equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing updates to meet regulatory requirements.
Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of pharmaceutical microbiology.
Developing on last years’ success, Pharmaceutical Microbiology UK 2020 will bring together industry experts to discuss and analyze the latest advancement and challenges within pharmaceutical microbiology. Discover how you can keep up with regulatory changes, and maintain the utmost efficiency during production and testing.
Highlights for 2020
• Discuss the regulatory expectations and supportive guidance on bio-contamination control and monitoring in aseptic manufacturing of sterile products from PHSS
• Gain valuable insight from key opinion leaders in a panel discussion on the impact of the Annex 1 revisions on pharmaceutical microbiology
• Examine the common myths and urban legends in the pharmaceutical industry related to contamination control from STERIS
• Explore container closure integrity and controls strategies ensuring product sterility from AstraZeneca
• Revisit the role of the Official Medicines Control Laboratories as the GMP back up from Infarmed IP
Testimonials from previous attendees:
“Great presentations of relevance to pharmaceutical microbiology. Some valuable learning and networking’”- AstraZeneca
“I really enjoyed the conference and how most presentations linked well with the other topics presented”- MHRA
“Well organised conference with a good variety of topics!!” – GSK
Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist, Drug Substance External Manufacturer, QC Scientists, Heads of Quality, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeial Scientist, Analytical Standards Specialist
Allergan Biologics Ltd; Allergy Therapeutics; Allergy Therapeutics UK; AllergyTherapeutics; AstraZeneca; Atalmedial; Baxter Healthcare Ltd; Biomerieux; bioMerieux UK Limited; Boehringer Ingelheim; BPL; British America Tobacco; Cancer Research UK; Cell and Gene Therapy Catapult; Ceutiqus; CGT - Catapult ; CGT (Cell & Gene Therapy Catapult) ; ChargePoint Technology; Charles River; Copan Group; Copan Italia SpA; Dupont De Nemours (Luxembourg) S A; DuPont de Nemours Luxembourg sarl; Fresenius Kabi; Fresenius Kabi UK Ltd; Fujifilm Wako Chemicals USA Corp; Genzyme Geel; Greiner Bio-One; GSK; GSK Vaccines; International Serum Industry Association; Ipsen; Kings College London; Medicines & Healthcare products Regulatory Agency (MHRA); MeiraGTx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; Microrite, Inc.; Novo Nordisk; Oak Zone Biotech; Pharmaceutical and Healthcare Sciences Society; Roche Diagnostics Deutschland GmbH; Royal Free Hospital; RSSL; Sanofi; Sanofi Pasteur; Steris Corporation; Synthon Chile; TEVA Runcorn; Teva UK Ltd; The LFB Group; University of Southampton; University of Veterinary Medicine Vienna; zac vventures inc;
8:30 Registration & Coffee
9:00 Chair's Opening Remarks
Olivier Chancel, Sterility Assurance Expert, Boehringer Ingelheim
Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility and Aseptic Practice Assurance Expert and Senior Quality Auditor. Used to work in or with the pharmaceutical industry for 20 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.
Published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices, has cowritten several books and also presented/moderated at various industry forums in Europe, Asia and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG...)
9:10 Regulatory expectations and supportive guidance on Bio-contamination control and monitoring in Aseptic manufacturing of sterile products
James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS
James Drinkwater is Head of Aseptic processing technologies & GMP compliance for F Ziel Germany, supporting international projects from a base in the UK. As a subject matter expert in Barrier separation technology; Isolator / RABS and hydrogen peroxide vapour bio-decontamination, James is involved in applications of sterile pharmaceutical product Filling, Aseptic processing of APIs/ ATMPs and Sterility testing.
In addition to the role at F Ziel James has a voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society and leads the PHSS Aseptic processing & Bio-contamination special interest group.
• Regulatory requirements e.g. Annex 1, 2, Regulatory expectations e.g. Q&A, Blogs, supportive GMP Guidance e.g. PHSS, BioPhorum (BPOG) – how they relate and current harmonization initiatives.
• Preparation of a Contamination Control Strategy (CCS) – an Annex 1 requirement and Considerations in preparation of an Aseptic-Containment Strategy (ACS) if toxic or biologically active products are aseptically processed and/or cross contamination control is required.
• Risk based rationale and supporting risk assessments to setting environmental monitoring locations and sampling frequencies – PHSS and BPOG collaboration initiative.
9:50 The Story Behind the Microbiological Data – and the Possible Paths Away from Recurring Events
Henrietta Vinneras, Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Mrs Vinnerås has been in the industry since year 2000 and has worked for pharmaceutical and medical device companies such as Pfizer, Abbott, GE Healthcare, Thermo Fisher Scientific and currently at Fresenius Kabi. Mrs Vinnerås is part of a global competence center supporting mainly the companys’ pharmaceutical manufacturing, medical devices and compounding centers world-wide with e.g. establishing global corporate procedures, on-site assessments, education and training, trouble shooting, root cause investigations, CAPAs and continuous improvement projects; specifically within the areas of microbiology and aseptic technique. She is also a member of the PDA Journal of Pharmaceutical Sciences and Technology editorial board.
• When we are using the CCS our monitoring activities will also result in OOT’s and OOL’s for our environmental monitoring data – and even OOS’s for endotoxins, sterility tests or bioburden – and then what happens?
• How do we approach the event via data, trend evaluation, non-conformance reporting, additional testing/sampling, investigational tools and risk assessments?
• How do we establish proper CAPA’s and effectiveness checks as part of our continuous improvement initiatives to prevent recurrence?
• The talk also builds upon cases from industry to help explain the events
10:30 Morning Coffee
11:00 Panel Discussion: The Impact of the Annex 1 Revision on Pharmaceutical Microbiology
• Which RMM technologies are being used without regulatory conflict on microbiological sampling results - Is industry ready for integration of digital platforms?
• The removal of contamination risk from operators through use of gloveless cells and robotics in filling platforms
• What does the unity of environmental classification, qualification and process monitoring mean to EM programs and data management of total particulate and microbiological samples?
• How do we manage risks associated with aseptic manufacturing of toxic and biologically hazardous products such as EM sample contamination, product cross contamination and personnel exposure?
• Assessing the disinfection rotation section on the use of multiple disinfectants to prevent the development of resistant strains – is there enough evidence?
• Revisiting the potential latent risk of VBNC and stressed microbial contamination in sterile product manufacturing
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
Tim Eaton B.Sc. (chemistry) has over 25 years’ experience of steriles manufacture with Zeneca Pharmaceuticals and AstraZeneca. During this time he has had extensive roles in technical support, production management and specialist activities for aseptically prepared products. He has had responsibilities for the design, construction, start up and validation of multimillion pound aseptic manufacturing facilities and has managed the introduction, technical transfer and scale up activities for a number of sterile products. He has published a number of papers relating to cleanroom activities and has also presented at various industry forums in Europe, Asia and the US.
In his current role of Sterile Manufacturing Specialist he has responsibilities for the derivation, optimisation and implementation of best practices for aseptically prepared products. He sits on LBI/30, the British Committee for Cleanroom Technology.
Jim Polarine, Technical Service Manager, Steris Corp
Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.
Di Morris, Audit Manager CAGá, Gsk
12:00 Automation for incubation and colony counting of Environmental Monitoring samples: process optimization and data integrity
Sonia Allibardi, Market Access Manager, Copan Group
Molecular biologist with a specialization degree in Biochemistry Science. Currently working in the Scientific Team of COPAN as Market Access Manager for the implementation of innovative Medical Devices in pre-analytics focusing on Italy, Eastern Europe and Asia Pacific Market. Her professional life started in a research Cardiovascular Physiology laboratory at San Raffaele Scientific Institute, Milan Italy, where She worked for more than 10 years and published scientific papers on International Journals. The objective of her research was the evaluation of myocardial metabolism in hypoxic and ischemic heart. In 2011, thanks to the “Mad Cow Disease”, She started a new job in Biorad Company. She spent three years as scientific product specialist in the life science division for Italy and Southern Europe (Spain, Greece, Portugal). She moved to Cepheid Europe for five years where her main topics were: Women’s Health, Hospital Acquired Infection and Tuberculosis.
Gabriele Savoldi, Business Development Manager, Copan Group
Mechanical engineer with master’s degree in Biomechanical engineering. In Copan since 2013, currently in charge of the business development of Copan’s automations in the industry field, notably in the food, cosmetics and pharmaceutical sectors.
12:40 Networking Lunch
13:40 Mycoplasma Safety of ATMPs
Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
Prof Renate Rosengarten’s career originated from her academic research work which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she has been Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria. Besides her numerous former functions and activities in organizations and committees, such as President of the International Organization for Mycoplasmology (IOM), President of the Austrian Society for Hygiene, Microbiology and Preventive Medicine (ÖGHMP), Scientific Advisory Board Member of the German Robert Koch Institute (RKI) in Berlin, and Working Group Leader of the Mycoplasma Task Force of the Parenteral Drug Association (PDA), Prof Rosengarten has long-standing entrepreneur and business experience in the area of mycoplasma safety testing. In addition to her academic duties as mentor, lecturer, reviewer, scientific advisor, and committee member, Prof Rosengarten serves since 2004 as an independent mycoplasma expert, key opinion leader and consultant for biopharma, biotech and cell therapy companies under her own international brand Mycosafe® and has recently established a consulting and licensing enterprise.
Mycoplasmas as contaminants in manufacturing processes of ATMPs
Features of mycoplasmas with respect to their contamination potential
Uncommon mycoplasma species as contaminants
Primary mycoplasma entry points
Product-relevant mycoplasma species for ATMPs
Risk and suitability assessments as important basis for implementing rapid batch release testing of ATMPs
Evaluation of which mycoplasma species are product-relevant and which commercial PCR test system is most suitable to detect them
Selection of the right panel of mycoplasma reference standards for product-specific PCR validation
14:15 New At-line Automated Mycoplasma Testing: A Performance Evaluation of BioFire Mycoplasma
Sylvanie Cassard Guilloux, Global solution Manager, BioMérieux
Sylvanie has a strong scientific background (PhD at Paris VII University; post-doctoral experience at Rockefeller University) in cellular and molecular biology. On her return to France, Sylvanie joined industry, and had 13 years of experience as technical leader or in R&D in several laboratories, developing and using molecular methods for industry quality controls, while she also participated to standardization of these methods as a group leader at the french normalization body (AFNOR). In 2012, after a Master of Business at Audencia business school, she joined the global marketing department of bioMérieux, where she is defining and guiding the development of new solutions for pharmaceutical microbiological controls.
• Current methods description
• New technology: how it works? What are the benefits?
• Internal validation data according to Pharmacopeia guidelines
14:55 Effective Risk Management of Microbial Contamination
• Risk assessment methods for microbial contamination
• Quantification of microbial contamination using environmental monitoring data
• Meaningful cleanroom environmental monitoring and Annex 1 considerations
• Effective risk based monitoring locations utilising appropriate risk factors
15:30 Afternoon Tea
16:00 Current status of the MAT and rFc
Ingo Spreitzer, Deputy head Section Microbial safety, Paul Ehrlich Institut
My former research topics (Lectins) and immune-activating components of bacteria introduced me to preparation /purification and bioassays, which until today influences my work on immune-activating / pyrogenic substances. I started at the PEI 2001 with the development and validation of the Monocyte activation test (MAT).
My current duties as deputy at the PEI are drug QC by LAL (all methods) and Pyrogen testing (former rabbit pyrogen test, now replaced by MAT) and scientifically the exploration of the MAT. Our actual interests are drugs with intrinsic pyrogenicity, Outer membrane vesicles, synergistic effects and low Endotoxin recovery (LER).
• Foreseen modification of MAT 2.6.30.
• Feedback on draft rFc 2.6.32.
• European and global situation of MAT and rFc
16:35 Monocyte Activation Test: The Superior Choice for Testing Medical Products and Protecting Patients from Contamination
Shabnam Solati, CEO & Co-Founder, CTL-MAT
Shabnam Solati developed a Monocyte Activation Test to meet the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to building the future of MAT beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.
• Presenting the MAT as a robust, reproducible, sensitive and human specific pyrogen testing
• An end-to-end process: MAT kit generation, test performance and product-specific validation
• Presenting the solution to the recent EP criteria: MAT as risk assessment for the endotoxin test and replacement of RPT
• The solution for pyrogenicity tests of medical devices
17:15 Microbial Control Considerations for Tablet Manufacture
Sophie Drinkwater, QC Technical Officer, AstraZeneca
I’m a microbiologist at AstraZeneca, where I have worked for almost 5 years; I’ve spent most of that time in the QC Microbiology labs, but recently I had the opportunity to spend 18 months in Pharmaceutical Technology & Development; this has led to collaborative studies in supporting the microbial control strategy of our oral solid dosage forms and sterile products. I’ve recently transferred to the role of a Technical Officer, where I will be driving microbiology method development and optimisation, including the implementation of modern microbiology techniques.
• Overview of microbial control strategy of the manufacture of oral solid dosage forms
• Summary of three laboratory based challenge studies
o Growth potential of microorganisms in coating suspensions
o Behavior of microorganisms in tablet coating processes
o Survival of microbes in wet granulation processes
• Application of Water Activity for risk-based testing plans
17:50 Chair’s Closing Remarks and Close of Day One
9:10 Common Myths and Urban Legends in the Pharmaceutical Industry Related to Contamination Control
• Disinfectant Quantity – The misconception that more disinfecting agent is always better for sanitization of surfaces.
• Microbiological Resistance – The misconception that micro-organisms will develop resistance over time to the use of disinfectants.
• Disinfection Rotation – The misconception that disinfection rotation is required to prevent microbiological resistance (i.e., Myth #1).
• Effectiveness of Isopropyl Alcohol¬ – The misconception that 70% Isopropyl Alcohol (IPA) is effective for control of fungal and bacterial spores.
9:45 Container Closure Integrity and Controls Strategies Ensuring Product Sterility
Lin Tan, CCIT Scientist, AstraZeneca
Lin’s current position is CCIT scientist functioning under Device Functionality, Safety, and Digital Connectivity team within AstraZeneca’s Dosage Form Design and Development Group. Lin is responsible for the development, qualification and transferring of container closure integrity test (CCIT) methods to support all programs across sites, providing SME level technical supports among project teams, resolving CCIT challenges during product life cycle, and supporting commercial operations. In addition, Lin is responsible for developing novel CCIT approaches for atypical container closure systems. Prior to AstraZeneca, Lin worked as CCIT scientist at both GlaxoSmithKline and Whitehouse Analytical Laboratories supporting multiple biopharmaceutical programs. Lin has a B.S. in Biological Science from Shenzhen University and M.S. in Pharmaceutical Manufacturing from Stevens Institute of Technology.
• Explore and learn when the utilize the different container closure integrity (deterministic and probabilistic) test methods mentioned in FDA guidance and USP <1207>
• New technologies with increased sensitivity…what is a good detection limit to target and when to draw the line
• How and when to utilize microbial challenge to help set manufacturing parameters
• Holistic approach in defining your container closure integrity controls strategy and aseptic assurance
10:50 Online Microbial Monitoring for Process Control of Pharmaceutical Waters
James Cannon, Head of OEM and Markets, Mettler-Toledo Thornton
James B. Cannon is Head of OEM and Markets at Mettler-Toledo Thornton. He has a BSc in Biology, degrees in Microbiology and Biophysics and an MBA in Marketing and International Management.
Mr. Cannon has over 35 years of experience in the management, design and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialisation of electrodeionisation modules.
Mr. Cannon is currently involved in the standards and regulatory organisations for the Semiconductor, Photovoltaic and Pharmaceutical markets, and the commercialisation of alternative microbial technology.
• Current state of real time microbial detection technology
• Case studies for the implementation of online microbial monitoring at pharmaceutical facilities
• Guidance for evaluation and establishment of new microbial limits
• The Pharmacopeia and Regulatory positions on validation of alternative microbial methods
11:30 Commissioning of a brand-new cleanroom facility from the environmental monitoring perspective
Maria Jose Zafra-Domene, QC Microbiologist, MeiraGTx
Originally from Spain, Maria relocated to the UK after completing her MSc in Biotechnology at the University of Granada. Maria began working as a QC Microbiology Technician in environmental monitoring at Nice Pak International in Flint (Wales), a wet wipes non-cleanroom manufacturing site. From here, Maria established her cleanroom environmental monitoring knowledge at Fresenius Kabi in Runcorn (England). After 6 years, she took on the position of QC Microbiologist in MeiraGTx, a gene therapy start-up based in London. Drawing from her experience, Maria has developed the environmental monitoring programme of a brand-new cleanroom facility within MeiraGTx. Now, she leads a team of QC Microbiology Technicians.
• The challenges of commissioning a brand-new facility
• Risk assessment of the cleanroom and the processes
• Establishing a routine Environmental Monitoring programme
12:05 Bacterial Endotoxins Test – Why are my CVs so high?
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.
• What is correlation of variation and how to apply it in BET
• What causes high CVs in BET
• How to identify the root of high CVs
• How to mitigate high CVs
13:45 Annex 1 Revision
• History of Annex 1
• Current Annex 1 key elements
• Early indicators of the changes expected in Annex 1
• Industry comments regarding the draft published in 2017
• Where now for Annex 1?
Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma
Recently established SDA Pharma Limited with co-managing Director Mike Davies. With almost 80 years’ experience in the industry SDA can provide a wide range of services form facility design and Qualification support to bespoke training and regulatory compliance advice.
My role in GSKs Global Quality was responsible for setting and monitoring Quality standards for the Global Manufacture and Supply division for pharmaceutical sterile manufacturing operations worldwide. Following the merger of GlaxoWellcome and SmithKlineBeecham in 2000 I established a team of subject matter experts to establish a common set of compliance standards for the new GSKs Quality Management System. I continued to lead that team right up to my retirement in 2018.
14:20 Aseptic Audit Observations
Di Morris - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; Pharmaceutical industry for over 30 years/ a number of years as a Medicines Inspector for the MHRA. Di/worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs/worked with a wide range of dosage forms including sterile products, biological, and non-sterile products.
• What auditor/inspector expectations are
• What audit finding classifications can be used
• Examples of audit observations
• Keeping up to date
14:55 Microbial Robustness in Product Design
Mitesh Patel, Principal Microbiologist, GSK
Dr Mitesh Patel has over 16 years industrial experience where he has built his microbiological expertise in veterinary, nutritional and most recently consumer health (CH) R&D. Mitesh graduated with a BSc in Biological Sciences an MSc from the University of Nottingham in Medical Molecular Microbiology and a PhD in Epidemiological Microbiology from the University of Birmingham. Within CH R&D he has led microbiology innovations and simplifications in product risk management adopting a Quality by Design (QbD) model to deliver market complaint and microbiologically robust products to consumers on time, every time.
• Impact of product design on manufacturing
• Going beyond Pharmacopeia Requirements
• Assessing the effectiveness of Microbial controls
16:00 Importance of Microbiological Standards for Personalized Medicines and Compounding
• Review of current trends and practices in EU and US
• Implementation of technological advancements and other best practices
• Review of new guidances, guidelines, and regulatory enforcement activities
• A look into the future of global personalized medicine
Jason McGuire, Vice President, Global Quality, Fagron
Jason has spent nearly 20 years in the health care industry serving in many roles with a particular focus on Quality control operations, Quality assurance and regulatory support. He’s a microbiologist by education and expertise, spending 2 years on the bench developing anaerobic microbial catalysts for fuel ethanol production. For the last 15 years, he has worked with non-sterile and sterile compounding facilities, national health systems, medical device, biotechnology and pharmaceutical companies helping them troubleshoot and bringing resolution to complex challenges.
16:35 Microbial Risk Assessment for Non-Sterile Oral Dosage Forms
David Elder, Constultant, David P Elder Consultancy
Dr. Elder has 42 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in formulation, microbiology and analytical method development.
Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is the chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 18 book chapters, 147 papers in international journals and has given 19 webinars and over 167 presentations at national/international symposia. He has 9 patents to his name.
He has co-edited a book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines (with Andy Teasdale and Ray Nims).
• Problem statement
• Risk Assessments
• Control strategy
• Objectionable organisms
• Conclusions
17:10 Chair’s Closing Remarks and Close of Day Two
David Elder
Constultant, David P Elder Consultancy
Di Morris
Audit Manager CAGá, Gsk
Gabriele Savoldi
Business Development Manager, Copan Group
Henrietta Vinneras
Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Ian Symonds
Director, Pharmaceutical Consultant, SDA Pharma
Ingo Spreitzer
Deputy head Section Microbial safety, Paul Ehrlich Institut
James Cannon
Head of OEM and Markets, Mettler-Toledo Thornton
James Drinkwater
Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS
Vice President, Global Quality, Fagron
Jim Polarine
Technical Service Manager, Steris Corp
Lin Tan
CCIT Scientist, AstraZeneca
Maria Jose Zafra-Domene
QC Microbiologist, MeiraGTx
Principal Microbiologist, GSK
Olivier Chancel
Sterility Assurance Expert, Boehringer Ingelheim
Renate Rosengarten
Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
Shabnam Solati
CEO & Co-Founder, CTL-MAT
Sonia Allibardi
Market Access Manager, Copan Group
Sophie Drinkwater
QC Technical Officer, AstraZeneca
Sylvanie Cassard Guilloux
Global solution Manager, BioMérieux
Tim Eaton
Sterile Manufacturing Specialist, AstraZeneca
Veronika Wills
Manager, Technical Services, Associates of Cape Cod
View details Associates of Cape Cod Sponsors http://www.acciusa.com/acc/index.html Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1- > 3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.
View details bioMérieux Sponsors http://www.thepeoplebehindthescience.com bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.
View details COPAN Sponsors http://www.copangroup.com With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com
View details CTL-MAT Sponsors http://WWW.CTLMAT.COM CTL-MAT - The MAT Company has been established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test - measuring endotoxins and non-endotoxin pyrogens alike.
View details METTLER TOLEDO Sponsors http://www.mt.com METTLER TOLEDO Thornton has a long history of delivering real time, continuous measurement products specifically designed for regulated pharmaceutical water systems such as Conductivity, TOC, and Ozone. The 7000RMS Real time Microbial System instantly detects and counts microbial (bioburden) presence enabling increased sensitivity, better process control, improved product quality, and reduced risk.
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View details Microbiologics Exhibitors http://www.microbiologics.com At Microbiologics, our mission is: "To provide the highest quality biomaterials for a safer, healthier world." We are the leading provider of ready-to-use QC microorganisms for quality control testing in the clinical, pharmaceutical, food, water and educational industries. With over 900 strains available in a variety of user-friendly formats, we offer the largest and most diverse line of QC microorganisms including qualitative, quantitative, Certified Reference Material and Parasite Suspensions. Our products are manufactured in accordance with the industry’s highest standards. We have achieved ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. In addition, we are an FDA registered establishment and offer many CE Marked products.
View details Microgenetics Exhibitors https://microgenetics.co.uk/
Microgenetics is a biotech company specialising in microbiology, with two products currently:
•	SmartControl, allowing easy capture and analysis of microbiological environmental monitoring data and is pre-validated for GMP compliance
•	SwiftDetect, an ultra-sensitive rapid sterility test capable of detecting a single cell in a large sample volume in 6 hours
View details RSSL Exhibitors http://www.rssl.com RSSL provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located in the UK and with our team of more than 300 dedicated employees, we ensure that every project is performed with our commitment to outstanding quality, scientific excellence and customer satisfaction. We offer a large portfolio of, chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle.
View details Veltek Associates Inc Exhibitors www.sterile.com Veltek Associates, Inc. (VAI) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with our environmental air sampling equipment to determine levels of contamination present in the air, Veltek is committed to providing our customers with the highest quality products.
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Official Media Partner
View details Rapid Microbiology.com Official Media Partner https://www.rapidmicrobiology.com rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.
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View details American Pharmaceutical Review Supporters http://www.americanpharmaceuticalreview.com Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy
View details Biocompare Supporters http://www.biocompare.com Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.
View details Contract Biotechnology Supporters http://www.contract-biotechnology.com Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.
View details Drug Development Technology Supporters http://www.drugdevelopment-technology.com Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.
View details Drug Discovery Today Supporters http://www.drugdiscoverytoday.com/ Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.
View details Drug Target Review Supporters http://www.drugtargetreview.com Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.
View details Farmavita Supporters https://farmavitar.com FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!
View details Gate2Biotech Supporters http://www.gate2biotech.com Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.
View details Genetic Engineering News Supporters http://www.genengnews.com Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx
View details IPI Supporters http://www.ipimediaworld.com IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.
View details Mednous Supporters http://www.MedNous.com MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com
View details MedTube Supporters https://medtube.net/
View details Pharmaceutical Technology Supporters http://www.pharmaceutical-technology.com Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.
View details Pharmalicensing Supporters http://www.pharmalicensing.com Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.
View details pharmaphorum Supporters http://www.pharmaphorum.com pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com
View details Pharmavision Supporters http://www.pharmavision.co.uk PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.
View details SciDoc Publishers Supporters http://www.scidoc.org SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.
View details Swiss Biotech Association Supporters http://www.swissbiotech.org/ The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.
View details World Pharma News Supporters http://www.worldpharmanews.com/
view all Supporters Sponsor the conference
Pharmaceutical Microbiology Workshop Day
Copthorne Tara Hotel
Scarsdale Place, Kensington, London, United Kingdom
The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.
The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.
Current Attendees 2020
Speaker interview with Ian Symonds
Speaker Interview with Olivier Chancel
Speaker Interview with David Elder
Speaker Interview with Gabriele Savoldi
Speaker Interview with James Cannon
Speaker interview with Dr. Ingo Spreitzer
Pharmaceutical Microbiology UK Infographic
Chair Invite Letter
Pharma Microbiology Workshop Day 22 Jan 2020
Pharma Microbiology 2020 Speakers
Pharmaceutical Microbiology UK Brochure 2020
Pharma Microbiology 2020 2-day agenda
Past Attendees 2017-2019
PAST PRESENTATION 2019 - Di Morris - GSK
PAST PRESENTATION 2019 - Laurent Leblanc - Biomerieux
PAST PRESENTATION 2019 - Thierry Bonnevay - Sanofi Pasteur
PAST PRESENTATION 2019 - Olivier Chancel - Boehringer Ingelheim
PAST PRESENTATION 2019 - Dr. Sonia Allibardi - COPAN Italia
Associates of Cape Cod
http://www.acciusa.com/acc/index.html
Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1- > 3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.
http://www.thepeoplebehindthescience.com
bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.
http://www.copangroup.com
With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com
CTL-MAT
http://WWW.CTLMAT.COM
CTL-MAT - The MAT Company has been established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test - measuring endotoxins and non-endotoxin pyrogens alike.
http://www.mt.com
METTLER TOLEDO Thornton has a long history of delivering real time, continuous measurement products specifically designed for regulated pharmaceutical water systems such as Conductivity, TOC, and Ozone. The 7000RMS Real time Microbial System instantly detects and counts microbial (bioburden) presence enabling increased sensitivity, better process control, improved product quality, and reduced risk.
Microbiologics
http://www.microbiologics.com
At Microbiologics, our mission is: "To provide the highest quality biomaterials for a safer, healthier world." We are the leading provider of ready-to-use QC microorganisms for quality control testing in the clinical, pharmaceutical, food, water and educational industries. With over 900 strains available in a variety of user-friendly formats, we offer the largest and most diverse line of QC microorganisms including qualitative, quantitative, Certified Reference Material and Parasite Suspensions. Our products are manufactured in accordance with the industry’s highest standards. We have achieved ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. In addition, we are an FDA registered establishment and offer many CE Marked products.
Microgenetics
https://microgenetics.co.uk/
RSSL
http://www.rssl.com
RSSL provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located in the UK and with our team of more than 300 dedicated employees, we ensure that every project is performed with our commitment to outstanding quality, scientific excellence and customer satisfaction. We offer a large portfolio of, chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle.
www.sterile.com
Veltek Associates, Inc. (VAI) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with our environmental air sampling equipment to determine levels of contamination present in the air, Veltek is committed to providing our customers with the highest quality products.
Rapid Microbiology.com
https://www.rapidmicrobiology.com
rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.
Biocompare
http://www.biocompare.com
Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.
American Pharmaceutical Review
http://www.americanpharmaceuticalreview.com
Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy
Drug Development Technology
http://www.drugdevelopment-technology.com
Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.
http://www.ipimediaworld.com
IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.
SciDoc Publishers
http://www.scidoc.org
SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.
Drug Target Review
http://www.drugtargetreview.com
Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.
Mednous
http://www.MedNous.com
MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com
Drug Discovery Today
http://www.drugdiscoverytoday.com/
Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.
http://www.pharmaceutical-technology.com
Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.
Genetic Engineering News
http://www.genengnews.com
Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx
Pharmalicensing
http://www.pharmalicensing.com
Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.
Swiss Biotech Association
http://www.swissbiotech.org/
The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.
Contract Biotechnology
http://www.contract-biotechnology.com
Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.
Gate2Biotech
http://www.gate2biotech.com
Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.
World Pharma News
http://www.worldpharmanews.com/
pharmaphorum
http://www.pharmaphorum.com
pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com
http://www.pharmavision.co.uk
PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.
MedTube
https://medtube.net/
https://farmavitar.com
FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!
Scarsdale Place
London W8 5SR