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The case study, which discusses a fabricated monoclonal antibody cartesian product, referred to equally “A-MAb,” was formulated over the of course of a class by participants of the working grouping representing Abbott, Amgen, Genentech, GlaxoSmithKline, Eli Lilly, MedImmune, and Pfizer.
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What was the QBD model case study of a-MAB?
QbD Model Case Study of MONOCLONAL ANTIBODY : A-Mab. This provided an opportunity to demonstrate how to utilize knowledge from a number of sources including prior knowledge with similar molecules and experience from in-vitro, non-clinical, and clinical data for assessing the criticality of a quality attribute.
What is the CMC biotech working group case study?
Product Development and Realisation Case Study A-Mab The CMC Biotech Working Group Page 11 of 278
Which is a case study in bioprocess development?
A–Mab: A Case Study in Bioprocess Development. This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.
Who are the participants in the a-MAB case study?
The case study, which discusses a fictional monoclonal antibody product, referred to as “A-MAb,” was developed over the course of a year by participants of the working group representing Abbott, Amgen, Genentech, GlaxoSmithKline, Eli Lilly, MedImmune, and Pfizer.
Last Update: Oct 2021
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