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Digitimes Research: Samsung, Apple, LG rank as top-3 smartphone vendors in 3Q14
Mobile + telecom | 1h 18min ago
TWM expects to reach 1.0 million 4G users at end of 2014, says president
Mobile + telecom | 1h 39min ago
Compatibility, efficiency crucial to wireless charging market: Q&A with Mark Hunsicker, senior director of wireless power solutions at Qualcomm
Bits + chips | 1h 45min ago
Taiwan October unemployment rate down, says DGBAS
Bits + chips | 2h 33min ago
China market: B2B e-commerce trades in 3Q14 valued at CNY4.85 billion, says Analysys
IT + CE | 2h 35min ago
Digitimes Research: Taiwan makers will ship over 24 million handsets in 4Q14
Mobile + telecom | 2h 42min ago
- Commentary: Xiaomi facing challenge to sustain growth
- Digitimes Research: Taiwan LCD driver IC revenues to rise 6% in 2014
- Japan-based Murata sees potential in IoT and wearable industries
- Falling LED bulb prices put pressure on LED driver IC firms
- China IC design houses expand presence in touch IC and fingerprint sensor markets
- Foxconn and Innolux to build 6G LTPS panel plant
- IBM, Cisco leading in smart city technology developments, says Navigant
- Acer unveils Aspire Switch and Iconia tablets
- China market: Online advertising value over CNY43 billion in 3Q14, says Analysys
- China has 1.277 billion mobile phone users in October, says MIIT
- Taiwan market: CHT to expand multimedia on demand services
- China and US boost worldwide industrial semiconductor market in 2014, says IHS
- Asia Neo Tech expects sales growth in 4Q14
- USI raises funds
- Corning announces glass advancements with Gorilla Glass 4
- Touch panel pricing to drop to US$1 per inch
- China Mobile expected to reach 70 million TD-LTE users at end of 2014
- Win Win Precision cooperates with vendor to market HeatCap in Japan
- Acer to launch convertible touch-screen Chromebook in 1H15
- Monocrystalline solar cell prices may fall in 4Q14, say Taiwan makers
- TSMC to offer InFO packaging for 16nm chips in 2016, says paper
- Digitimes Research: China makers Bitland, BYD to join Chromebook supply chain in 2015
- Medical equipment makers investing in new facilities in Taiwan
- Foxconn to build airborne logistic hub in Zhengzhou
- Taiwan estimated to supply 20% of global IC packaging materials, says IEK
24-Nov-2014 markets closed
|TSE electronic
|OTC electronic
- Apple reportedly to push Beats to all iPhones (Nov 19) - BBC News
- Android Lollipop update causes problems (Nov 19) - BBC News
- Xiaomi accelerates internet content plans with $300m Iqiyi stake (Nov 19) - The Financial Times
- Android Lollipop arrives for HTC's Google Play handsets this week (Nov 18) - ZDNet
- Nokia says no return to handsets as CEO lays out its plans for the future (Nov 14) - ZDNet
- BlackBerry and Samsung partner to provide end-to-end security for Android (Nov 13) - Company release
- Former iPhone user sues Apple over missing text messages (Nov 11) - eWeek
- HP and Nokia join forces to build cloud-based networks for operators (Nov 12) - InfoWorld
- Digitimes Research: Samsung, white-box players looking to take over 10-15 million feature phone demand from Microsoft Mobile
- Digitimes Research: Taiwan makers ship over 18 million smartphones in 3Q14
- Digitimes Research: Tablet-use AP shipments in China grow slower than expected in 3Q14
- Digitimes Research: Tablet AP shipments in China to rise 4.7% in 4Q14
- Releases
- White papers
- Bulletin
- Last Mile to Conquer: Tatung's Bendable Optical Cables Cleverly Resolve Problems Related to Optical Fiber Establishment
- Wilocity showcase WiGig solution for mobile phone
- Conexant debuts AudioSmart software for PCs, tablets
- Edge-Core Networks to showcase next generation cloud networking service with advanced could-based wired and wireless solutions at Computex 2014
- u-blox launches TOBY-L2, the fastest 4G LTE modules with 3G, 2G fallback in the world
- Fujitsu converts Fujitsu Toshiba Mobile Communications into a wholly owned subsidiary
- NEC reaks the speed barriers of microwave transmission with ultra high modulations
- LSI completes acquisition of SandForce
- Fujitsu introduces ARROWS Z ISW11F au smartphone
- PSCo Technical Distribution partners with Matrox to offer fully integrated turnkey video walls
- Digitimes Research: Samsung, white-box players looking to take over 10-15 million feature phone demand from Microsoft Mobile
- Digitimes Research: GTAT woes disrupt sapphire industry
- Digitimes Research: Enterprise segment to benefit, but PC segment to suffer from HP spin-off
- Digitimes Research: China 4G smartphone demand fails to surge; CoolPad, Lenovo, Xiaomi unlikely to achieve 2014 targets
- Digitimes Research: Microsoft to release new inexpensive notebook solution; unlikely to receive full support from vendors
TD-LTE is the mainstream global choice for 4G asymmetric frequency spectrum networks
HTC has launched its flagship smartphone M8
Apple pushing iPhone 6 Plus manufacturing
Apple has been pushing iPhone 6 Plus manufacturing in order to satisfy strong demand from the Asia Pacific region.
Apple iPhone 6 and Apple Watch
Apple has announced its new iPhone 6, 6 Plus and Apple Watch on September 9
Karbonn looks to in-house handset production in India: Q&A with executive director
Karbonn, the second-largest India-based handset vendor, is looking into in-house production. Digitimes...
Gaining an advantage in emerging markets: Q&A with India-based handset player Micromax
Sales of handsets in the India market reached 61.07 million units in the first quarter of 2014, with...
On the handset market in India and increasing presence of Lava: Q&A with Lava chairman Hari Om Rai
As India's handset market is continuing to grow, local vendors including Lava, Spice, Intex and GI...
India government looks forward to cooperating with Taiwan to develop local handset industry: Digitimes president talks with top officials from India's Ministry of Communications & IT
During Digitimes president Colley Hwang's recent trip to India, he had the opportunity to meet with...
- Smartphone and tablet industry: The view from Taiwan - May 2012
Taiwan-based companies have a long and successful history of involvement in the supply chain for mobile devices, which for the purposes of this article consist...
- Taiwan handset overview - Jun 2010
The global handset market did not have a banner year in 2009, with overall shipments of 1.167 billion units representing a drop of 3.2% from the previous year,...
- Taiwan handset industry overview - Jun 2008
The use of handsets continues to grow around the world, both in mature and emerging markets, as the communication devices become ever more ingrained in people's...
- Taiwan handset overview - Jun 2007
Global handset shipments topped 977 million units in 2006, according to Digitimes Research, with Taiwan-based handset makers accounting for 14% of the market on...
- 2014 global high brightness LED market, trends and shipment forecast
For the global LED lighting market, the market size will reach US$25.82 billion in 2014 or a market penetration rate of 23.4%. This is attributable to exponential shipment growth for light bulbs, tubes, and directional lamps.
- Greater China touch panel shipment forecast through 2015
This Special Report provides forecasts through 2015 for Greater China touch panel shipments with breakdowns based on technology (glass, film, resistive), application (smartphone, NB and tablet) and by firm.
- 2014 global tablet demand forecast
This report analyzes the main players, their strategies and shipments forecasts for 2014, as well as other factors contributing to either growth or decline in various segments within the tablet market, with a particular focus on Apple, Google, Samsung, and Microsoft, along with whitebox vendors.


text:
BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using
Vanden Boom (Hospira): Generally, upstream critical quality attributes for a cell-culture manufacturing process are limited to the adventitious agent
and bioburden testing of the cell-culture harvest material. This also holds for biosimilar products.
It should be noted that knowledge of an association between cell-culture steps with certain product quality attributes is
not a result of implementing a QbD approach but, rather, a result of knowledge gained through the basic scientific and engineering
endeavors that should be elements of developing a bioprocess.
Rathore (IIT Delhi): In the past, most CQAs could not be measured directly in the fermenter broth due to the interference from the numerous components
present in the broth. As a result of major advancements in analytical science, direct measurements of CQAs are performed in
bioprocessing today. These would be product-quality related parameters, including host-cell impurities (e.g., host-cell proteins,
DNA), process-related (e.g., Protein A leachate), and product related (e.g., aggregate, basic variants, acidic variants, and
glycoxylation pattern). Some of these CQAs, such as glycoxylation pattern for monoclonal antibody (mAb) products, are primarily
impacted by the upstream process and are particularly important to monitor during process development.
Weber (CMC Biologics): The goal of a QbD approach is to develop additional knowledge of the impact of upstream process unit operation performance
on the final purified product quality. The most likely or desired outcome is to develop a quantifiable correlation between
upstream process outputs, such as cell viability or viable cell density (VCD), and product attributes, such as glycosylation.
This approach can lead in the determination of CQAs for the cell production bioreactor unit operation. Upstream outputs classified
as CQAs have proven to be controversial, because the bioreactor is so far upstream from the final product. However, if a strong
correlation can be established between VCD/viability and other CQAs or final product specifications, this can be an appropriate
Girard (Spinnovation): The underlying concept for QbD of an upstream bioprocess is that the desired quality of the biological or biopharmaceutical
product is assured every time. CQAs vary for each cell line depending on the nature of the bioprocess, with typical critical
qualities such as metabolites and contaminants. CQAs usually include properties that affect product quality and eventually
overall performance of the bioprocess. CQAs are typically also release tests, although they don't have to be as there are
no real release tests as such in upstream processing.
The variability and complexities associated with the upstream biological process make QbD a complex process, one that relies
on defining operation specific critical process parameters (CPPs). CPPs are those likely to impact on the quality of a product
or intermediate. For biological products, process control can be difficult to define and implement. O2 pressure, catalyst concentration, and pH are examples of critical parameters. It is important to note that mAbs are currently
the leading area of biopharmaceutical research. One of the key parameters to monitor in the implementation of QbD in mAb production
is the glycosylation process during formulation. Glycosylation is one of the overriding contributors to mAb heterogeneity
and has significant implications for the function of the antibody in vivo and immunogenicity. This means that glycosylation has been isolated as a critical parameter to follow during mAb manufacture.
QbD for mAb development with specific glycosylation patterns enables researchers to optimize manufacturing and clinical efficiency.
Johanning (QAtor): The QbD concept works its way back so to speak from the patient to product to process and ultimately to the facility. A risk
assessment will outline the risk profile in and between each area.
The starting point for the risk assessment is R&D, which upstream has determined the CQAs on the product. CQAs are often product
specifications, including eventual GMP requirements (if GMP is used as part of the biopharmaceutical process, which is often
the case in multinational pharma companies in order to ensure a fast-track initiative from R&D to license to operate and market).
The risk assessment includes a review and assessment of the products CQAs when manufactured on specific equipment.

subset: commoncrawl


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