Featured Outsourcing Editorial
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Maintaining Harmony With Your CDMO Using 'The Middle Way'
10/31/2024
Sponsor and CDMO relationships are fertile ground for conflict. A measured approach can mitigate disruptions with troublesome contractors and high performers alike.
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A Comprehensive Guide For Supplier Quality Agreements
10/29/2024
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.
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Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
10/29/2024
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
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Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
10/28/2024
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.
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How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials
10/25/2024
Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.
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Safety Cabinets' Essential Role In EU GMP Annex 1
10/25/2024
A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.
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Life Sciences Cybersecurity Incident Management: The End-to-End Approach
10/24/2024
Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.
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Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning
10/24/2024
BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.
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Exploring Sanofi R&D's Batch Monitoring Initiative
10/23/2024
The project established predictability during testing and release for the production of medicine to support clinical trials.
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What's Next After FDA's DSCSA Extension?
10/18/2024
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.