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From: TSS (216-119-129-13.ipset9.wt.net)
Subject: Re: [Docket No. 04-116-1] USE of veterinary biological products on the topic of Transmissible Spongiform Encephalopathies (TSS SUBMISSION)
Date: November 5, 2004 at 1:17 pm PST

In Reply to: [Docket No. 04-116-1] USE of veterinary biological products on the topic of Transmissible Spongiform Encephalopathies (TSS SUBMISSION) posted by TSS on November 5, 2004 at 10:05 am:

-------- Original Message --------
Subject: Bovine-derived Products Used in the Manufacture and Formulation of Vaccines: Current Policies and Issues for the Future
Date: Fri, 5 Nov 2004 15:06:53 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

2004 PDA/FDA Joint Regulatory Conference - 9/20-22/2004

Bovine-derived Products Used in the
Manufacture and Formulation of
Vaccines: Current Policies and
Issues for the Future
William M. Egan, Ph.D.
Acting Director
Office of Vaccines Research and Review
September, 2004 
FDA/PDA Meeting
Examples of Bovine-derived Products
Used in Vaccine Manufacture
" Fetal calf serum
" Beef muscle/organ extracts
" Gelatin/processed gelatin
" Small molecules (amino acids, peptides,
lactose, Tween, glycerol)
CBERs Policy Regarding the Sourcing
of Bovine-derived Materials
[T]hat manufacturers & assure that materials
derived from all species of ruminant animals
born, raised, or slaughtered in countries where
BSE is known to exist, or countries where the
USDA has been unable to assure FDA that BSE
does not exist, are not used in the manufacture
of FDA-regulated products intended for
administration to humans.
[April, 2000, CBER Letter to Manufacturers of Biological
Products]
CBERs Policy Regarding the Sourcing
of Bovine-derived Materials
" May, 1991, CBER Letter to Manufacturers
" December, 1993, FDA Letter to Manufacturers
" May, 1996, FDA Letter to Manufacturers
" September, 1997, FDA Guidance for Industry on the
Sourcing and Processing of Gelatin
" April, 2000, CBER Letter to Manufacturers of
Biological Products
" May, 1993, Points to Consider in the Characterization
of Cell Lines used to produce Biologics. (This
guidance document is being updated)
Vaccines not Following
CBER/FDA Recommendations
" In early 2000, through a product review, CBER
learned that its recommendations were not
universally followed for all vaccines.
" Risk estimates for various situations were carried
out and CBER developed recommendations for
the affected manufacturers.
" Discussed in a joint session of the TSE Advisory
Committee and Vaccines and Related Products
Advisory Committee (7/2000).
Recommendations of the July, 2000
Joint Advisory Committees
" Bovine-derived materials used in the routine
production of vaccines that are sourced from
countries on the USDA list should be replaced
with bovine-derived materials from countries not
on the USDA list
" Working bacterial and viral seed banks and
WCBs that were established with bovine-derived
material from countries on the USDA list should
be re-derived with bovine-derived materials from
countries not on the USDA list
Recommendations of the Joint
Advisory Committees (contd)
" Master viral and bacterial seed banks that were
established with bovine-derived material from
countries on the USDA list need not be rederived
with bovine-derived materials from
countries not on the USDA list.
" These issues are of public interest and the public
should be informed about the safety of vaccines
that used materials from countries on the USDA
list and the assessment of the nature of any risk
for vCJD from such vaccines.
Update from 2000 Meeting
" Web site created containing transcript of AC
meeting, risk assessments, and listing of
affected vaccines with periodic updates;
www.fda.gov/cber/bse/bse.htm.
" New sources of bovine materials found and
used in manufacturing.
" Working cell and seed banks re-derived,
qualified, and placed into production.
" Nearly all of the affected vaccines are now
out of date
The Policy is Clear, But &
Source country control can be problematic when
new countries are added to the list:
 Licensed products remain on the market
 Manufacturing time-lines are long (> 1 year)
 The status of master cell and seed banks, as
well as working cell and seed banks, become
unclear; re-derivation and re-qualification take
time and may not always be possible
 The status of products in development (pre-
IND through BLA) becomes unclear
 Risk  benefit decisions continue to be needed
EMEA Guidance on Minimizing the Risk of
Transmitting Animal TSE Agents via
Medicinal Products
" Revision of 1/28/04; date of application of the
note is July 1, 2004
" Undertaken to introduce, inter alia, risk
assessment into the regulatory compliance
process, clarify terms and classifications, and
take into account advances in scientific
knowledge
" Use of the revised WHO infectivity classification
scheme
" Guidance applied prospectively
Vaccines and North American
Sourced Bovine Materials
" BSE-infected cows found in Canada and the U.S.,
the latter being born in Canada
" Bovine-derived materials from cattle that are
born, raised, or slaughtered in the U.S. and
Canada are used in U.S.-licensed vaccines and
vaccines under development.
" OVRR has not requested that vaccine
manufacturers replace existing Canadian or U.S.
sources of bovine-derived material.
USDA Proposed Rule re: Canada
" USDA proposed rule [October 31, 2003;
http://www.aphis.usda.gov] to allow for, inter
alia, import of:
 Bovine animals less than 30 months of age for
immediate slaughter
 Fresh meat from carcasses of bovines less than 30
months of age; specified organs/tissues
" USDA will review comments as it makes any final
decision on the importation of certain live
ruminants and ruminant products from Canada
and other minimal risk regions for BSE.
FDA Interim Final Rule (IFR): Use of Materials
Derived from Cattle in Human Food (including
dietary supplements) and Cosmetics
" July 14, 2004 [Federal Register Volume 69,
Number 134; pages 42255 - 42274
" Interim final rule in response to finding of an
adult cow, in the State of Washington, imported
from Canada, that tested positive for BSE
" Prohibited materials are defined
" Consistent with recent USDA IFR
" FDA is currently considering changes to the
ruminant feed ban regulation
US FDA Interim Final Rule: Use of Materials
Derived from Cattle in Human Food (including
dietary supplements) and Cosmetics
" Prohibited cattle material mean specified risk
materials (SRMs), small intestine of all cattle,
material from nonambulatory disabled cattle,
material from cattle not inspected and passed, or
MS (beef).
" SRMs mean brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (with certain
exclusions), and dorsal root ganglia of cattle 30
months of age and older and the tonsils and distal
ileum of the small intestine of all cattle.
Medicinal Products
A rule for medicinal products (human
drugs, biologics, and medical devices,
as well as veterinary drugs) is
currently being developed by FDA.
Areas for Consideration
" Replacement of animal-derived materials with
non-animal-derived or synthetic materials
" Use of serum-free cell culture systems
" Use of closed herds as a source of bovine
materials, especially for higher risk materials,
when such materials are needed.
" Replacement of human serum albumin with
recombinant albumin
Areas for Potential Research
" Ability of cells (CHO cells, Vero cells,
MRC-5 or WI-38 cell, etc.) to propagate
the BSE agent, if present [see, e.g.,
I. Vorberg, A. Raines, B. Story, and S.
A. Priola, Susceptibility of common
fibroblast cell lines to TSE agents, J.
Infect. Dis., 189, 431-9 (2004)]
" Ability of various manufacturing steps
to clear the BSE agent, if present

http://www.fda.gov/cber/summaries/pda092004we.pdf

2004 PDA/FDA Joint Regulatory Conference - 9/20-22/2004

* Bovine-derived Products Used in the Manufacture and Formulation of
Vaccines: Current Policies and Issues for the Future
William M. Egan, Ph.D. - (PDF)

http://www.fda.gov/cber/summaries/pda092004we.pdf

TSS

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