Contract Pharma Manufacturing editorial
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Quick Takes From Takeda Austria’s Annex 1 Rollout
3/25/2024
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
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Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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How To Measure Cell Density In Real Time With Soft Sensors
3/21/2024
Soft sensors can enable real-time monitoring of key process variables, including viable cell density. Here's how one team at Takeda put them to use.
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Considerations For Robust Implementation Of The Multi-Attribute Method
3/19/2024
USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.
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Impacts Of The Inflation Reduction Act (IRA)
3/18/2024
Jesse Mendelsohn, a "pharmaceutical regulatory compliance and government pricing” guru, who manages a life sciences group of over 100 consultants, says currently the biggest disruptor to our industry in 2004 is the Inflation Reduction Act (IRA), the 2023 legislation passed by Congress and signed into law by President Biden.
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BIO Expels WuXi, Agrees With U.S. Government
3/14/2024
“BIO is taking steps now to separate from WuXi-AppTec regarding membership in the organization," says Biotechnology Innovation Organization President & CEO John F. Crowley. But to Chief Editor Louis Garguilo, this seems like a strange company to target.
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What Investors Teach Us About CDMO Selection
3/12/2024
“My advice to a biotech when outsourcing to a CDMO is really understand what you want. I don’t mean this as a criticism, but selecting a CDMO is most often not within your circle of competence." Advice on overcoming that deficit from a successful biotech and CDMO investor.
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What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
3/8/2024
Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.
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Process Development: Stuck In The Middle With You
3/8/2024
There is pressure to accelerate programs out of research, and into development. Then, despite the complexity of new drugs, therapies and technologies, process development chemists are asked to quick-step to clinical grade, and commercial-ready material. For their part, CDMOs need to react to it all.
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Shocking! Biotech Facilities Don't Maintain Themselves
3/4/2024
Don't get trapped in the misconception that only core process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.