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From: TSS ()
Subject: Concerns Over BSE, or Mad Cow Disease and FDA Regulation Has Contributed to Decreased Use of (FBS) Fetal Bovine Serum in Biomanufacturing
Date: July 6, 2006 at 1:25 pm PST

Concerns Over BSE, or Mad Cow Disease and FDA Regulation Has Contributed to Decreased Use of (FBS) Fetal Bovine Serum in Biomanufacturing
7/4/2006 9:00:00 AM EST
BIOWIRE

Research and Markets (http://www.researchandmarkets.com/reports/c39059) has announced the addition of Cell Culture: Media, Sera, and Reagents to their offering

The culturing of cells requires nutrients from media, sera, and reagents and is used for research, process development, and biomanufacturing purposes. In recent years, with ongoing consolidation activity, the market has been dominated by fewer major suppliers, led by Invitrogen, Fisher Scientific (with its HyClone subsidiary), and JRH Biosciences. Only the largest players can compete as suppliers in the therapeutic production and manufacturing space, but smaller players, particularly Mediatech (with its Cellgro brand), are gaining significant market share in academic and industry research segments. Niche markets like stem cell research will grow in size and importance, given encouraging news like the recent $3 billion voter-approved bond in California to fund stem cell research over the next ten years. In addition, media consumption levels, especially for specialty and custom serum-free formulations, are on the rise, fuelled by biologics like monoclonal antibodies, vaccines, and recombinant proteins that are in the pipeline or commercially marketed. In parallel, fetal bovine serum (FBS) use has decreased significantly in biomanufacturing applications, due to concerns over Bovine Spongiform Encelphalopathy (BSE, or Mad Cow disease) and FDA regulations. However, according to our interviews with academic and industry end-users, FBS usage continues to be prevalent within research segments. With the worldwide and US cell culture markets experiencing steady double-digit growth, the market landscape is poised for more competition, especially amongst companies able to expand their sales and marketing initiatives and develop new products adapted to different cell lines. From extensive interviews with cell culture purchasing decision-makers, we identify, analyze, and recommend specific strategic tactics for companies aiming to grow revenues and increase market share.

For more information visit http://www.researchandmarkets.com/reports/c39059

CONTACT:

Research and Markets Laura Wood press@researchandmarkets.com Fax: +353 1 4100 980

http://www.genengnews.com/news/bnitem.aspx?name=3136793

24 Jul 00 Trade Statistics: UK to US
Compiled by Terry S.Singeltary Sr of Bacliff, Texas

[Opinion (webmaster): The US has focused for years on tracing, containing, and eradicating live animal imports from the UK or other countries with acknowledged BSE like Belgium, including some 499 cattle and the Vermont sheep. This strategy does not acknowledge imports of rendered bovine products from England during the BSE period nor secondary products such as surgical catgut, which is to say surgical cowgut, or dairy cattle embryos, vaccines for veterinarian and human medicines. What has become of these?

Mr. Singeltary, who lost his mother to CJD of unexplained origin a few years back and went on to became a well-known TSE activist, has tracked down voluminous pertinent import data through correspondence with UK officials and searches of government web sites. Imports of such products are frequently cited by Europeans in rating BSE risks in the US and in shutting out US exports.

Many people's eyes glaze over when reviewing reams of sometimes older trade statistics. There is no proof that any of the imported products was contaminated with BSE nor if so, any evidence that any BSE product lead to infection in US livestock, surgical patients, or what not. Nonetheless, the data obtained by Mr. Singeltary establish that an appalling variety and tonnage of products that were imported by the US from the UK and othr BSE-affected countries during the peak of the BSE epidemic years.]

10 January 1990 COMMERCIAL IN CONFIDENCE

NOT FOR PUBLICATION

COMMITTEE ON SAFETY OF MEDICINES
WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY

snip...see full text here ;

http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh

The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL


snip...

Did the US import fetal calf serum and vaccines from BSE-affected countries?

3002.10.0040: FETAL BOVINE SERUM (FBS)
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)

http://www.mad-cow.org/00/may00_news.html#aaa

TWA LITTLE minute


http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf


COMMERCIAL IN CONFIDENCE


http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf


NOT FOR PUBLICATION


http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf


http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf


NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE


snip...


I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out... http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf more on the 1968 medicine act, they forgot to follow


http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf


Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)

http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf


(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)


http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf


http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf


TWA LITTLE STATEMENT 331


http://www.bseinquiry.gov.uk/files/ws/s331.pdf

TSS






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