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Multiple modalities in Pharma manufacturing
Pharma industry manufacturers are considering how advanced therapy medicinal products (ATMPs) and other traditional modalities can be combined within the same facility or within a newly constructed agnostic building.
As manufacturers look to make better use of manufacturing space and sites, Multi-modality manufacturing is getting greater attention across the industry. Having pre-invested manufacturing spaces or buildings simply awaiting clean room installation is also growing in popularity. This allows manufacturers to respond rapidly to new market approval or increased demand for a new modality.
A big question is what differing modalities are acceptable for multi-modality manufacturing? Similarly, do certain modalities simply require a dedicated facility?
The topic is the cover feature in the latest issue of ISPE's 'Pharmaceutical Engineering' magazine. PM Group's Tom Bannon, Advanced Therapies SME, and Alf Penfold, Regulatory SME, address these and other questions related to multi-modality manufacturing.
Taking a scientific and risk based approach, Tom and Alf have developed a method for answering these questions. Further, they have proposed escalating design and operation requirements when considering higher risk modalities.
Read the full article in the November / December issue of 'Pharmaceutical Engineering' magazine (ISPE Members only):