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Key Features of a Biosafety Program for the Biopharmaceutical Industry (single user digital version)

By Jessica Avizinis

PDF Single user
Gov. Price: $45.00Member Price: $55.00Nonmember Price: $69.00
  • Description
  • Table of Contents
  • Author's Bio

Here are robust discussions of microbial identifications in a new light.

This reprint from Microbial Control and Identification: Strategies, Method and Applications edited by Dona Reber and Mary Griffin demonstrate how microbial identification knowledge is a cornerstone in the concept of microbial and contamination control programs.

The complete text contains more remarkably informative chapters. For details about content, a complete table of contents and ordering information please visit: go.pda.org/MCID

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Format: PDF (1 file 756 KB)

Table of Contents:

  • Relevance of Biosafety to Drug Development, Manufacturing and Testing Operations
  • The Importance of Biosafety: Impacts of Exposure
  • Key Features of a Biosafety Program
  • Future Biopharmaceutical Biosafety — Special Challenges
  • Conclusion
  • References

About the Author

Jessica Avizinis is the Biosafety subject matter expert (SME) in Pfizer's Global Environment, Health and Safety organization. Her career in research safety and biosafety spans about 10 years including academic and industrial experience, previously serving as the Biosafety Officer at Brown University and member of Brown's Institutional Biosafety Committee (IBC) and Animal Care and Use Committee (IACUC).

Currently Jessica supports several projects at Pfizer Inc. in Research and Development (R&D) as well as clinical/commercial manufacturing in biotechnology including gene therapy. She supports the EHS external supply team to assess biosafety capabilities at contract researcher, manufacturing, supplier and vendor facilities. She leads Pfizer's Biosafety Network driving improvements in strategy and biosafety practices across the enterprise.

Jessica also serves as the secretary for the Pharmaceutical Benchmarking Group (PBG), a group of biosafety professionals in the biopharmaceutical industry who meet annually to identify industry best practices, as well as a community member of a US government research facility IBC. She holds a B.S. in Wildlife Conservation Biology and an M.S. in Medical Laboratory Science and she is a Registered Biosafety Professional under the American Biological Safety Association (ABSA) International.

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