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 in the News
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ISPE Training: Critical Utility GMP Compliance, Online Live, 12-15 May
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Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
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US to Require Placebo-Controlled Studies for New Vaccines
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Scientists Question NIH Vaccine Project
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Companies Advised to Maintain Inspection Readiness
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Some EU, US GMP Standards Differ
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Recyclable Packaging Suitable for Cold Transport
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Drug Delivery Device Trends Include Reusable, Gas-powered Injectors
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SK Pharmteco Adds GMP Plasmid Suite at Pa. Plant
- Work begins on Lilly's $4.5B Medicine Foundry in Ind.
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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…
Stage 3 Process Validation: Applying Continued Process Verification Expectations
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and…
