PDA Published Books/Booklets

Proceedings from the PDA Workshop on Mycoplasma Contamination by Plant Peptones

Entering into the 21st century, the regulatory agencies and the pharmaceutical industry developed effective risk management programs to minimize the risk of mycoplasmal contamination in manufactured biopharmaceuticals. The proceedings contain important presentations which will provide readers with recent information offered by subject matter experts who presented at the 2005 PDA Workshop on the contamination of plant peptones.

Appropriate quality risk management programs have been instituted by:

  1. Identifying the problem
  2. Avoiding high risk biologically-based raw materials
  3. Developing a close working relationship between the vendor of the biologically-based raw materials and the purchasing manufacturer,
  4. Additional treatment and/or testing of these raw materials as needed upon QC receipt.


Table of Contents:
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Introduction (Click here to download >>> Introduction )

  • Mycoplasma Biology
  • Industry Experience with Mycoplasma Contaminations
  • FDA Viewpoint
  • Animal and Plant Peptones: Vendors Viewpoint on Control of Mycoplasma
  • Mycoplasma Removal-Vendors Viewpoint
  • Mycoplasma Testing
  • Questions & Answers

  • Date of Publication: August 2007
    ISBN Number: 0-939459-17-5
    Format:
    Number of Pages: 257
    Binding: Hardcover