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Achieving business and operational excellence in the pharmaceutical industry
(Massachusetts Institute of Technology, 2008)
Historically the pharmaceutical industry has been highly profitable. However, the increasing regulatory requirements, bargaining power of buyers, and drug failures together with the threat of biosimilars and decreasing R&D ...
Implementation of the new FDA quality by design guidance in pharmaceutical production
(Massachusetts Institute of Technology, 2008)
Due to the highly regulated environment, it is difficult to implement changes to a pharmaceutical process. Even small change request approvals can require months of effort for pharmaceutical companies and regulatory agencies. ...
Lean transformation methodology and implementation in biopharmaceutical operations
(Massachusetts Institute of Technology, 2008)
Amgen's Operations division is responsible for the production, release and distribution of commercial and clinical products. Due to industry consolidation, impending competition and revenue impacts, Amgen is facing the ...
The conclusion of a biologic's lifecycle : manufacturing sourcing strategies on the eve of follow-on biologics
(Massachusetts Institute of Technology, 2008)
The Amgen Rhode Island facility is dedicated to the production of the biological bulk drug substance (BDS) for Enbrel® (etanercept), which blocks the action of one's immune system, helping to treat immune diseases, such ...