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Issue 5 2023

 

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Developing micro QC for ATMPs

3 January 2024 | By

In this Q&A, Natalie Saunders, Interim Head of Quality Control at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on quality control.

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Elevating pharmaceutical manufacturing processes with real-time insights

4 December 2023 | By

(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at how this transformative approach…

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Challenging applications of capillary electrophoresis in biopharmaceutical analysis

1 December 2023 | By ,

After decades of development and refinement, the separation of proteins by capillary electrophoresis (CE) has moved beyond the R&D laboratory into the manufacturing quality control laboratory. Here, Giuseppe Peddio and Federica Bisceglia discuss the advancements in CE technology for development applications and batch release for biopharmaceutical products.

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Guide to Outsourcing 2023

14 November 2023 | By

In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.