Outsourced Pharma Editorial
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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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A Guide To Proactive Supplier Management In The Pharma/Biotech Industry
3/21/2024
Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.
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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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Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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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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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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A New Model Approach To Drug Shortage Prevention
3/15/2024
The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.
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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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Doubling Down On Biopharma’s Growing Skills Drought
3/13/2024
The biopharmaceutical industry is building manufacturing capacity at breakneck speed. According to PhRMA, there are 1,580-and-counting biopharma manufacturing facilities in the U.S. alone. Problem is, we're way short on filling those facilities with skilled labor. NIIMBL wants to change that. Here's how, and a great opportunity for big pharma, biotech sponsors, CDMOs, academics, and more to help.