Biomanufacturing Featured Articles
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Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
5/1/2024
The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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Unpacking The Importance Of Lipid Nanoparticle Production Platforms
4/15/2024
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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Ophthalmic Drug Delivery
4/11/2024
Explore the challenges to effective delivery of drugs to the eye, the intricacies of ophthalmic drug delivery, and the advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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Managing Supply Chain Risks Using Relational Risk Analysis
4/5/2024
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
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What Really Happens When A Cell Therapy Supply Chain Fails?
4/5/2024
A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.
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Best Practices For Clinical Supply Chain Management In Rare Disease Trials
3/27/2024
A supply chain pro discusses three of the greatest challenges in clinical trial supply management for rare diseases and strategies to overcome them.
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A Launchpad For Scalable Systems In AAV Gene Therapy Manufacturing
3/21/2024
Identifying a trusted supplier that can address the myriad of challenges that accompany development for AAV-based drugs is critical to securing an asset’s ultimate commercial success.
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How To Prevent And Manage Temperature Excursions In Clinical Trials
3/20/2024
Temperature excursions can have devastating effects on drug product for clinical trials. Here are some ways to avoid them and protect the cold chain.
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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.