Biotech COP Resources

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These resources are just one of the many benefits of being a Biotech COP Member.
Join the Biotech COP and ask questions in the community discussions and gain solutions to real-world problems.  Also, share your experience and expertise by responding to inquiries.

Note that only ISPE Members can engage in these activities.  If you are not an ISPE Member, join ISPE and take advantage of all the benefits that membership has to offer.

General Documents

  • The Business of Biotech and Innovation ( 268 KB)
    Presentation from Annual Meeting 2012 Executive Series Biotechnology Session by Melinda Richter, Founder and CEO of Prescience International.
  • A-Mab: A Case Study in Bioprocess Development
    Now Available: the final version of the CMC Biotechnology Working Group’s QbD case study entitled “A-Mab: A Case Study in Bioprocess Development”. This is the culmination of over a year of work by participants of the BWG representing Abbott, Amgen, Genentech, GlaxoSmithKline, Eli Lilly, MedImmune, and Pfizer, and work upon which PQLI will continue to build.

Knowledge Briefs

ISPE has developed concise, summary documents called Knowledge Briefs to help address the industry's need for current, relevant, and useful content.


Indicates content available to ISPE members only.