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45,500 | 320 | QUESTION:
Do you know the reasons why it was thought that the
procedure --
ANSWER:
Well, the agent -- the factors II, IX and X clottin g
factors were absorbed to the resin. It was very
likely that the infective agent wouldn't be absorbe d,
would remain in the supernatant and, therefore, it
could be concluded, possibly, that there would be
a reduction, in any event, of virus.
|
45,501 | 320 | QUESTION:
What was the basis for thinking that the virus --
ANSWER:
Well, the virus is very big and I don't think --
I think it wouldn't -- it subsequently turned out t o
be the case -- it wouldn't absorb or be bound to
a positively charged resin.
|
45,502 | 320 | QUESTION:
That is, you think, the reason for that final claus e
in the final sentence?
ANSWER:
Yes, yes.
|
45,503 | 320 | QUESTION:
Do I understand the start of that answer to be
that this idea --
ANSWER:
Yes.
|
45,504 | 320 | QUESTION:
-- insofar as it was exploited in PFC --
ANSWER:
Yes.
|
45,505 | 320 | QUESTION:
-- was that of Dr Smith?
ANSWER:
Yes, that of Dr Smith within PFC, but it was being
used in other places, other facilities.
|
45,506 | 320 | QUESTION:
If I could go, please, to electronic page 15 of
the document, internal page 455. This may follow f rom
the answers you've given already, if we look at the
second paragraph there, it is stated -- this is in the
concluding section:
"There is no reason to believe that the
concentrate cannot transmit serum hepatitis; howeve r
it is probably better in this respect than alternat ive
sources of factor IX, including plasma."
Do I understand from your previous answer that
the reason for that is the technique that was used was
thought to have a degree of viral inactivation?
ANSWER:
Yes, well, viral separation.
|
45,507 | 320 | QUESTION:
I'm going to take you to another article now, if
I may. It is again, one of yours. If we could hav e
PRSE0003799.
ANSWER:
Oh, right, yes.
|
45,508 | 320 | QUESTION:
This is the Journal of Laboratory and Clinical
Medicine from 1976 --
ANSWER:
Yeah.
|
45,509 | 320 | QUESTION:
-- volume 88, pages 91 to 101, "Removal of hepatiti s B
21 surface antigen ... from plasma fractions".
ANSWER:
Yes.
|
45,510 | 320 | QUESTION:
We can see the authors are Dr Johnson and his
colleagues from New York, and you and Jim Smith fro m
Edinburgh.
ANSWER:
Yes, yes.
|
45,511 | 320 | QUESTION:
You refer in your statement, the second of your bul let
points was -- sorry, third your bullet points -- wa s
"Clearance of Hepatitis B from Factor IX concentrat e
using polyethylene glycol precipitation".
ANSWER:
Yes.
|
45,512 | 320 | QUESTION:
Am I right in thinking that this article covers tha t
aspect of your work?
ANSWER:
Yes. Yes, it does.
|
45,513 | 320 | QUESTION:
Before we delve into it, could I ask you again for
a quick potted guide of what polyethylene glycol
precipitation is?
ANSWER:
Polyethylene glycol is a large, molecular weight
polymer and you can add it to solutions of protein
when it would cause precipitation of proteins in
a selective way, depending on their charge. And yo u
can, by adjusting the pH of the solution, adding th e
polyethylene glycol, you can get selective
precipitation of certain proteins. So size and
charge.
122 |
45,514 | 320 | QUESTION:
Size and charge. If we could look at the abstract,
please:
"Endogenous or deliberately added hepatitis B
antigen was removed and concentrated for assay from
albumin, and from coagulation factor II, VII, IX an d X
concentrates as model plasma fractions. The
concentrates carry considerable risk of causing
hepatitis in transfused patients. The amount of
antigen remaining in the fraction was estimated to be
less than 1/10,000 of that detectable by the Ausria II
radioimmunoassay and 1/100 of that found to be
infectious when highly contaminated human sera were
diluted and injected in chimpanzees. Batch
fractionation methods with polyethylene glycol were
used. The yield of albumin was 96 per cent and of the
coagulation factors about 90 per cent."
That's an overview there of the article.
Going to the first paragraph, it says:
"The high incidence of hepatitis from the
administration of blood and plasma fractions remain s
a serious problem despite governmental requirements to
pretest donors for the hepatitis B antigen ... Use of
the counterelectrophoresis (CEP) assay for screenin g
donors has reduced the overall incident of serum
hepatitis by nearly 30 per cent, and most
123 investigators feel that use of the more sensitive
radioimmunoassay ... has reduced it by about 50 per
cent. However, pretesting has failed to achieve
further reduction because of possible contamination of
the blood by infectious agents capable of causing
non-A, non-B hepatitis, and insufficient sensitivit y
of the assay."
Just pausing there for a moment, two factors
mentioned. One is the same as with the previous
article, there's a lack of sensitivity in the testi ng,
and the second is a reference here in this article
from 1976 to non-A, non-B hepatitis.
ANSWER:
Yes.
|
45,515 | 320 | QUESTION:
So plainly you were aware, at that stage, of non-A,
non-B hepatitis?
ANSWER:
Yes, which is now hepatitis C.
|
45,516 | 320 | QUESTION:
Yes. Can you recall how serious non-A, non-B was
considered to be, as a risk to potential patients a t
that time?
ANSWER:
Well, once again, at this time, the overall objecti ve
was to stop the patients from bleeding. And while we
were doing this work, obviously to try to improve t he
situation as far as the hepatitis was concerned,
that's all I was, sort of, aware of. Obviously, we
were aware of hepatitis. We had the agent -- we
124 developed these agents to try to stop bleeding firs t.
Second, we wanted to try and address the hepatitis
problem.
|
45,517 | 320 | QUESTION:
So that everybody is clear, your role as a biochemi st
was to work on those projects --
ANSWER:
Yes.
|
45,518 | 320 | QUESTION:
-- not to decide whether or not the treatment that
resulted from it should be given to a patient?
ANSWER:
No. I mean yes.
|
45,519 | 320 | QUESTION:
You agree with the proposition?
ANSWER:
Yes. [Laughs]
|
45,520 | 320 | QUESTION:
Do you recall what discussions were taking place at
around that time about other pathogens or potential
pathogens in blood products?
ANSWER:
In the 1970s?
|
45,521 | 320 | QUESTION:
Yes.
ANSWER:
No.
|
45,522 | 320 | QUESTION:
If I could turn, please, to electronic page 7 of th e
article. Forgive me, I think I miscounted.
Electronic page 8, please, internal page 98. This is
in the "Discussion" section. In the second paragra ph
down, it says:
"Our purpose has been to reduce the antigen
level in selected model plasma fractions, albumin, and
factor II, (VII), IX and X concentrates, to 105 or 104
25 particles per millilitre and then inject the materi al
in chimpanzees to determine its infectivity."
Am I right in saying this was a spiked sample
that would then be inserted into the chimpanzees?
ANSWER:
Yes.
|
45,523 | 320 | QUESTION:
It goes on:
"Albumin is normally heated to 60°C to prevent
hepatitis, but since this temperature would cause
inactivation, and factor II, (VII), IX and X
concentrates, they cannot be heated and carry a str ong
risk of causing hepatitis in recipients."
So albumin, it was known at that time, could be
subjected to a heat treatment at 60 degrees C.
ANSWER:
Yes.
|
45,524 | 320 | QUESTION:
But, according to this article Factor IX and the ot her
factors couldn't be?
ANSWER:
That's what was considered at the time: they couldn 't
be.
|
45,525 | 320 | QUESTION:
Do you know why that was considered so?
ANSWER:
Well, they were both -- they're all quite labile
proteins, which is subject to denaturation, whereas
albumin is known to be a very robust protein and ca n
be heated, and it was heated at 60 degrees for
10 hours, originally to remove bacteria.
|
45,526 | 320 | QUESTION:
Do you know if any work was going on within PFC at
126 that time about heat treatment --
ANSWER:
No.
|
45,527 | 320 | QUESTION:
-- of those factors?
ANSWER:
Not in those, no. Not at that time.
|
45,528 | 320 | QUESTION:
No, the work wasn't going on, or, no, you don't --
ANSWER:
No, the work was not going on. I'm not even sure
that -- in those days, we all believed what is said
here, that they can't be heat treated, and that was
what was believed at the time.
|
45,529 | 320 | QUESTION:
Received wisdom, as it were?
ANSWER:
Sort of received wisdom from what we knew about tho se
proteins.
|
45,530 | 320 | QUESTION:
But were there any discussions, as far as you recal l,
about the --
ANSWER:
It was --
|
45,531 | 320 | QUESTION:
-- possible --
ANSWER:
It was dismissed at the time as being unlikely to b e
possible, which is why we looked at this precipitat ion
method.
|
45,532 | 320 | QUESTION:
If we could go on to the next paragraph.
"In collaborative studies with Dr Hoofnagle, two
chimpanzees were injected with PEG-fractionated II,
(VII), IX and X concentrates which were known to be
infectious ..."
I'm afraid the copy isn't good here:
127 "... and contained at least 1011 antigen
particles per millilitre prior to PEG fractionation ."
That's polyethylene.
ANSWER:
Yes --
|
45,533 | 320 | QUESTION:
105.
ANSWER:
Yes, they didn't get a very good result.
|
45,534 | 320 | QUESTION:
It says:
"... one of the two injected animals" --
ANSWER:
Yes, "became infected".
|
45,535 | 320 | QUESTION:
-- "while the other did not ..."
ANSWER:
Yeah.
|
45,536 | 320 | QUESTION:
Could you just talk us through that aspect and the
significance, both of the previous method being use d
and the fact that one of the chimpanzees became
128 infected?
ANSWER:
Actually, I can't, because I'm not quite sure what
this actually meant, now, going back 40 years.
I apologise for that. I'm not quite sure what the
procedure was that was different.
|
45,537 | 320 | QUESTION:
But you say they didn't get a very good result,
whatever that procedure was?
ANSWER:
Was, it didn't seem to work.
|
45,538 | 320 | QUESTION:
Hadn't inactivated -- separated the --
ANSWER:
No, it hadn't separated it out.
|
45,539 | 320 | QUESTION:
I am just going to take you to see if we could perh aps
get some assistance from Peter Foster's evidence to
the Penrose Inquiry.
ANSWER:
Yes.
|
45,540 | 320 | QUESTION:
You're aware of Dr Foster?
ANSWER:
Yes.
|
45,541 | 320 | QUESTION:
He became a colleague of yours --
ANSWER:
Yes, he did.
|
45,542 | 320 | QUESTION:
-- in due course.
ANSWER:
Yes.
|
45,543 | 320 | QUESTION:
If we could have on screen, please, Soumik,
PRSE0003349, this is one of the documents that you
were provided with. If we could have page 3 -- sor ry,
just leave it there for one second, we can see this is
the witness statement of Peter Foster to the Penros e
29 Inquiry, or one of his witness statements.
If we could turn to page 3 of that, please, and
paragraph (f). It says -- Dr Foster said this:
"Factor IX preparing experimentally in the USA
by this procedure, from plasma known to contain
hepatitis B infectivity, was tested by Dr Johnson i n
chimpanzees. The chimpanzees developed hepatitis B ,
demonstrating that hepatitis B infectivity had not
been fully removed ..."
Then there is citation to the article which we
have just seen.
ANSWER:
Yes.
|
45,544 | 320 | QUESTION:
So, leaving aside the reference to whether or not i t
was one chimpanzee or two chimpanzees, it became
infected. Dr Foster's take from the paper, as it
were, is that the process hadn't been successful?
ANSWER:
Yes.
|
45,545 | 320 | QUESTION:
Or I should say wholly successful?
ANSWER:
Well --
|
45,546 | 320 | QUESTION:
It may have reduced --
ANSWER:
Not really successful -- it wasn't successful.
|
45,547 | 320 | QUESTION:
Yes, and that's a conclusion you would agree with?
ANSWER:
I would agree with that.
|
45,548 | 320 | QUESTION:
If we could just go to (g), then:
"Dr Johnson's subsequently refined for
130 precipitation parameters (the revised method being
known as the mark II method) to remain greater remo val
of the hepatitis B virus. However, he told me that
his application for funding for another chimpanzee
study, to discover if the removal of hepatitis B
infectivity had been successful, was rejected by th e
USA National Institute of Health (NIH) because they
considered that [and he quotes] 'hepatitis is no
longer a problem'."
ANSWER:
Oh, that's interesting.
|
45,549 | 320 | QUESTION:
Is that something you were aware of or can assist u s
with?
ANSWER:
No, I wasn't.
|
45,550 | 320 | QUESTION:
Sorry.
"... consequence of the very high dose of
factor IX that had been administered in this study, as
131 the product was more concentrated than established
Factor IX concentrates."
Were you aware of or involved in the Cash work
which led to the production of that article?
ANSWER:
Yes. We supplied the concentrates for it. Actuall y,
I was surprised because I didn't recall -- and I ha ve
read Peter's submission -- but I was surprised beca use
I -- it could have been because it was a very high
dose of Factor IX that was administered. That's al l
I can conclude from that.
|
45,551 | 320 | QUESTION:
Yes.
ANSWER:
And that -- because a lot of Factor IX, a lot of
Factor II, a lot of Factor X, that could be the res ult
of -- that could be resulting in this thrombogenici ty
that I referred to.
|
45,552 | 320 | QUESTION:
Yes, yes.
ANSWER:
But that was the Defix.
|
45,553 | 320 | QUESTION:
That was the Defix that you supplied Dr Cash --
ANSWER:
Yes.
|
45,554 | 320 | QUESTION:
-- for that article --
ANSWER:
Yes, yes.
|
45,555 | 320 | QUESTION:
So a slightly different stream of work?
ANSWER:
No, that was Defix. And what -- well, I think it
was -- I think that's what he's referring to. If y ou
go back to the page before, can you just ...
132 Oh, I'm apologising, sorry. He wasn't referring
to Defix.
|
45,556 | 320 | QUESTION:
We will pick this up with Dr Foster in due course.
ANSWER:
Yes, because when we went on to use the polyethylen e
glycol process that Dr Johnson had developed, we di d
a parallel, not -- we did it with no, obviously,
hepatitis added in, we did it just to look at the
fractionation of Factor IX, through this polyethyle ne
glycol process. We actually got a reduction in
thrombogenic material by tests that were introduced
later, which was again one of those publications th at
we had.
|
45,557 | 320 | QUESTION:
I am just going to take you back to the 1976 articl e
of which you were a co-author.
If we could have on the screen, please, Soumik,
PRSE0003799, internal page 99.
So I think page 8 of the electronic version.
I'm afraid I don't have a marked copy. Sorry, page 9.
ANSWER:
That's 98.
|
45,558 | 320 | QUESTION:
Thank you. I just want to take you to the final
paragraph:
"Although the clinical value of the PEG method
for removing [hepatitis B] must be confirmed by
further studies in chimpanzees, we fully expect tha t
its application to selected, clinically useful bloo d
33 fractions will reduce or even eliminate
post-transfusion hepatitis due to hepatitis B antig en
contained in these administered fractions."
Could you just explain the basis for that
thinking?
ANSWER:
Um ... well, I think ... there was only two
chimpanzees. The method was refined, and I think h e
felt that the use of a precipitation method to
precipitate out the virus, which is obviously very big
and very heavy, it -- theoretically, it would be
a good method.
|
45,559 | 320 | QUESTION:
Shall we read this as being that although there has
been infectivity with the mark I method --
ANSWER:
Yeah.
|
45,560 | 320 | QUESTION:
-- Dr Johnson is already thinking about the mark II
methods and is optimistic for the results that may be
obtained?
ANSWER:
Yes, yes.
|
45,561 | 320 | QUESTION:
We see an express reference to the need for further
chimpanzee studies.
ANSWER:
Yes.
|
45,562 | 320 | QUESTION:
We can tie that back to what Dr Foster said in --
ANSWER:
Mm.
|
45,563 | 320 | QUESTION:
-- and pick that up with him in due course. Thank
you.
134 One further article from your time at PFC -- or,
published after your time, but referring back to wh ile
you were there.
If we could have, please, WITN2235010. The
second page of this, please.
An article from British Journal of Haematology
in 1981, volume 47, pages 91-104, an article by
Dr Prowse and Dr Cash:
"The Use of Factor IX Concentrates In Man:
a 9-Year Experience of Scottish Concentrates in the
South-East of Scotland."
You are not an author of this paper.
ANSWER:
No.
|
45,564 | 320 | QUESTION:
It is published after you have left the PFC but wou ld
include periods that you were at the PFC if it's
a nine-year study; is that fair?
ANSWER:
Yes.
|
45,565 | 320 | QUESTION:
Did you have any role in the study to which this
article refers?
ANSWER:
No.
|
45,566 | 320 | QUESTION:
I will leave it there.
Returning to your witness statement, you also
say that while you were at the PFC, you were involv ed
in purification of Factor VIII from human blood usi ng
purified cryoprecipitate fraction. Could you just
135 briefly explain what that involved, please.
ANSWER:
Well, it was well known and was used, single donor
cryoprecipitate, which means that plasma was thawed
very slowly to not more than 5 degrees, and the
precipitate that was Factor VIII and fibrinogen, in
large proteins, was recovered.
This is a very slow process but it was single
donor, which was the advantage from the hepatitis
point of view. But it was very slow, and if a pati ent
was bleeding, it was not a particularly useful thin g
to do. So what I did, again with Dr Smith, was to
make bulk preparations of cryoprecipitate, which
essentially involved taking large amounts of plasma ,
thawing it out very slowly, with mixing, to get
a cryoprecipitate which would then be dissolved and --
essentially dissolved and formulated to make a bulk
product, which could be freeze-dried.
And that was the first Factor VIII to be made by
that method at -- in Scotland.
|
45,567 | 320 | QUESTION:
Very difficult question but can you remember the
time span in which you were engaged in that work, a nd
particularly when it came to -- (overspeaking) --
ANSWER:
Well, I did it almost when I first started my first --
in the first couple of years.
|
45,568 | 320 | QUESTION:
How -- may I ask a broad question: how
successful was the product that was created?
ANSWER:
Quite successful.
|
45,569 | 320 | QUESTION:
Was it used by clinicians in the --
ANSWER:
Oh, yes.
|
45,570 | 320 | QUESTION:
-- (overspeaking) --
ANSWER:
Yes, it was. In fact, after I left PFC, which was for
reasons of -- I had a husband who moved to the West
Coast of Scotland, and I went to Glasgow and worked
with a haemophilia director there, and was involved in
some of the treatment of patients -- for the first
time, really.
And they were using some of that concentrate,
and it just made such a difference to -- for the
patients to be able to have a freeze-dried concentr ate
used immediately out of the fridge for immediate us e.
|
45,571 | 320 | QUESTION:
This concentrate, shall we understand that it was
essentially a freeze-dried cryoprecipitate?
ANSWER:
Yes.
|
45,572 | 320 | QUESTION:
Rather than what became known as freeze-dried facto r
concentrates at a later stage, rather than pooled
plasma?
ANSWER:
It was -- I'm not sure I understand your question.
|
45,573 | 320 | QUESTION:
I'm sorry.
37 ANSWER:
It was a freeze-dried -- it was freeze-dried
cryoprecipitate, but made in bulk. So you got seve ral
hundred vials from a batch.
|
45,574 | 320 | QUESTION:
I see.
ANSWER:
That were freeze-dried.
|
45,575 | 320 | QUESTION:
So what was the pool size of the cryoprecipitate?
ANSWER:
Well, I know initially it was about 20 litres but
I can't remember how many units that -- how much th at
made, but ...
|
45,576 | 320 | QUESTION:
Obviously obtained from more than one donor at that
size?
ANSWER:
Yes, it was.
|
45,577 | 320 | QUESTION:
You said initially. Do you remember about --
ANSWER:
I don't know how high because it was being done in
a small facility, and using small scale equipment, and
therefore we were somewhat limited to about 20 litr es.
Now, I'm sure it went up to about 100 litres,
subsequently, about that's what I recall doing.
|
45,578 | 320 | QUESTION:
Same question as earlier. Were you involved in
any discussions about the potential risk of --
ANSWER:
No.
|
45,579 | 320 | QUESTION:
-- increasing the donor size?
ANSWER:
No.
|
45,580 | 320 | QUESTION:
Again, a decision made at a higher level?
ANSWER:
Yes.
|
45,581 | 320 | QUESTION:
The final bullet point you gave through PFC is the:
"Evaluation of Plasma Fractionation using solid
phase polyelectrolyte based on Ethylene Maleic
anhydride (EMA PE)."
ANSWER:
Yes.
|
45,582 | 320 | QUESTION:
Now with some trepidation, given that I attempted a n
139 explanation earlier, could I ask for your explanati on
of what polyelectrolyte fractionation is, please?
ANSWER:
Well, essentially it was just a novel polymer,
positively charged polymer, that was -- I can't
remember its original use from Monsanto but it was
being evaluated for plasma fractionation. And ther e
were variations on the degree of positive charge th at
could be introduced into it.
So there was one called E100, which was a 100
per cent substitute with positive charge, which was
used -- potentially which was developed to purify
albumin and gamma globulin away from each other. A nd
then there was -- the one that -- when I first
evaluated those polyelectrolytes, I went to New Yor k.
There was no -- from my recollection, and I think t his
was true, there was no polyelectrolyte at that poin t
that was very useful for Factor VIII. I don't know
whether it was because the Factor VIII wouldn't com e
off the polyelectrolyte. I suspect that was the ca se.
But at that time, there wasn't one.
So I ended up -- from PFC, I went over and
learnt about albumin and gamma globulin.
|
45,583 | 320 | QUESTION:
Was that at Dr Johnson's --
ANSWER:
That was in Dr Johnson's lab.
|
45,584 | 320 | QUESTION:
You mentioned Monsanto.
140 ANSWER:
Yes.
|
45,585 | 320 | QUESTION:
That was the company providing the polyelectrolyte?
ANSWER:
Yes.
|
45,586 | 320 | QUESTION:
Yes. And that's the same company as later provided --
ANSWER:
Yes.
|
45,587 | 320 | QUESTION:
Well, even at this time as was providing Speywood, and
you would --
ANSWER:
Yes. Yes.
|
45,588 | 320 | QUESTION:
Other than those areas that we've discussed, were y ou
involved in any other viral separation or viral
inactivation work in PFC at that time?
ANSWER:
Um ... no, only the creation of Supernine, which we 've
talked about, the PEG precipitated.
|
45,589 | 320 | QUESTION:
We will come back to Supernine perhaps with Dr Fost er
or with others.
ANSWER:
And I did actually -- yes. I did actually look at
separation of viruses with polyelectrolyte with imm une
globulins. But that's not -- that was never
published, so I am not quite sure -- but there
obviously was an awareness there of ...
|
45,590 | 320 | QUESTION:
Who was directing the areas in which R&D would be
aimed, in the PFC at that time?
ANSWER:
Um, Jim Smith. Dr Smith.
|
45,591 | 320 | QUESTION:
What resources were available to him?
ANSWER:
Plasma.
41 |
45,592 | 320 | QUESTION:
As in laboratory and human resources?
ANSWER:
In PFC?
|
45,593 | 320 | QUESTION:
Yes.
ANSWER:
Um ... we had laboratory, we had equipment. We had
plasma.
|
45,594 | 320 | QUESTION:
How many people?
ANSWER:
Doing research, or doing this development work?
|
45,595 | 320 | QUESTION:
Doing research.
ANSWER:
Well, there was me and I guess there was a couple o f
others, but it was mostly me doing coagulation
factors.
|
45,596 | 320 | QUESTION:
Fair to say then that there had to be a fair degree of
prioritisation on the work which you were doing?
ANSWER:
Mm.
|
45,597 | 320 | QUESTION:
We know that in 1981, after you had left, some
five years after you had left, the Medicines
Inspectorate gave a critical report of the PFC.
In your experience, up until 1976, did the PFC
meet the standards that you would have expected of
a laboratory and fractionation centre.
ANSWER:
Well, I didn't know any better. They -- we were --
well, we were obviously trying to work as cleanly a s
possible. The Medicines Act had only just really c ome
into play in 1969, so I think we were sort of -- it
sounds terrible but it isn't meant to -- making it up
142 as we went along. We had to keep out bacteria, we had
to keep out pyrogen in particular, and these were t he
things that drove us to work as cleanly as possible
and that's what we did.
But the facilities in PFC at the time -- and
this is before it moved into its new facility out a t
Liberton -- we were in the bowels of the Royal
Infirmary in Edinburgh, and in fact -- which was no t
a particularly desirable place to be making clean
blood products, but it was all we had.
|
45,598 | 320 | QUESTION:
How did it compare with your later experience of
Speywood?
ANSWER:
When I first went to Speywood the conditions were n ot
great. We were working in a Portakabin -- and
a garage, actually. So I got used to that sort of
thing, and, amazingly, made pyrogen-free products o ut
of -- in some of these facilities.
|
45,599 | 320 | QUESTION:
Is it fair to say that then both your initial work in
Speywood and the work that you did at the PFC, your
burdens were added to by the need to work hard to m ake
pyrogen-free product in the --
ANSWER:
Yes, it adds quite a lot of problems, and cleaning
equipment, and water quality, and those sorts of
things. So yes.
|
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