The business concept of a Custom Development and Manufacturing Organization (CDMO) is mainly to provide expertise and resources in a fee-for-service relationship during the development and supply of a biopharmaceutical.
This is a way for large Pharma and Biotechs to outsource development peaks, and limit the CAPEX and human costs. In this lecture, Bryan will go through the main areas of interest when a pharmaceutical company evaluates a CDMO. Whether you are in a position to outsource part of your production to a CDMO, or if you want to stand out in this race, this webinar should raise your interest.
Speakers
Bryan Lowery
Quality System Consulting, Inc.
Pharmaceutical Consultant
Bryan Lowery is a Pharmaceutical Consultant with Quality Systems Consulting, Inc, specializing in Operations and Lean Transformations. He started in the US Navy Nuclear Program before moving into the pharmaceutical industry as an Operations Lead focusing on Lean Transformations manufacturing sterile radiopharmaceuticals. He has held several Site Leadership roles in pharmaceutical and medical device operations and his recent background included serving as the Director of Operations for Thermo Fisher’s Biologics Facility before transitioning to a consulting role. He graduated in Nuclear Engineering Technology from Thomas Edison State College and earned a Master's degree in Quality Assurance (Lean Manufacturing) from California State University as well as an MBA from Webster University. He is a Senior Member of the American Society for Quality (ASQ) with several Quality Certifications and was recently selected as the President Elect of the Missouri Valley Chapter of the Parenteral Drug Association (PDA).
Microbiological testing
- Sterility testing
Duration:22min
Language:English
Session 1:presented June 16, 2021
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