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Prions: A Primer for the Biopharmaceutical Industry
Drug and Market Development Publishing, Feb 2005, Pages: 131
This Report offers valuable insight into the challenges encountered during manufacture of plasma-derived products or ruminant-sourced raw materials employed in biopharmaceutical manufacturing.
The Report highlights the importance of risk management in order to ensure biopharmaceutical safety from a prion-safety standpoint.
In addition, this Report provides information on the nature of prions based upon currently available knowledge, and covers specifically the issues that need to be addressed in biopharmaceuticals manufacturing in order to produce a safe and efficacious product and comply with the regulations.
This Report Will Benefit the Following Professionals:
- Heads of Process Development, R&D, and Manufacturing within the pharmaceutical, biopharmaceutical, and biotechnology industries involved in the production, QC and QA of biologicals and biotech-derived products.
- Start-ups who have limited knowledge of regulatory requirements, as well as contract manufacturers and consultants whose input is sought for risk minimization from a TSE-safety standpoint and adherence to regulatory requirements will also benefit.
About the Author:
Hazel Aranha, Ph.D., RAC is President of Gaea Resources Inc., a company focused on regulatory consulting and medical communications. She has a Master's degree in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC).
Her 28 years experience covers academia, industry, and consulting. She is a well-acknowledged authority in the area of virus and prion clearance from biologicals and biopharmaceuticals. She is currently on the PDA/FDA subcommittee for virus filter standardization and on the editorial advisory board of BioProcess International Journal. She has been a speaker at various forums on viral clearance in the United States and globally and has conducted courses for industry on virus clearance.
She is the Secretary of the local (NJ/NY) chapter of the Regulatory Affairs Professional Society (RAPS) and holds memberships in several organizations including the American Medical Writers Association (AMWA), American Society for Microbiology (ASM), Parenteral Drug Association (PDA), and the Society for Industrial Microbiology (SIM). She has to her credit over 40 publications and 4 book chapters. Prior to her current position, she was Manager, BioProcess Applications, Life Sciences Division at Pall Corporation, NY.
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