Content focuses on the interactions of multidisciplinary functions and discusses the scientific application of experimental design methodologies as part of the product manufacturing process. Individual topics could include formulation, clinical phases, manufacturing, technology transfer, production scale-up, and optimization.
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ISPE Academy's GMP Refresher Certificate Program
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ISPE Webinar: ISPE Clinical Supply Business Continuity Survey Results and Discussion
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Varda Raises $187M to Manufacture APIs in Space
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US FDA Drafts Aluminum Exposure Guidance for Parenteral Drugs
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Trump Threatens 200% Tariffs on Imported Pharma Products
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EU to Compile List of Critical Medicines for Stockpile
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Phlow Temporarily Halts Production After Roof Catches Fire
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Considerations for Designing Live Biotherapeutic Product Facilities
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Continuous Manufacturing for mAbs May Leave Smaller Environmental Footprint
- US FDA Layoffs Raise Concerns about Foreign Drug Plant Inspections
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White Papers
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
November / December 2023
There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
May / June 2022
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…
