Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
News|Articles|May 15, 2017
- Pharmaceutical Technology-05-15-2017
- Volume 2017 eBook
- Issue 1
Kill the Bioburden, Not the Biological Indicator
Author(s)James P. Agalloco
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
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The PNSU, probability of a non-sterile unit, is crucial to determining process conditions. However, the concept is often misapplied.
Sterile processing expert Jim Agalloco explains how the proper application of a biological indicator can guide the development of an effective sterilization process.
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Articles in this issue
over 9 years ago
Clean, Disinfect, and Validateover 9 years ago
Ensuring the Biological Integrity of Raw Materialsover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
Case Study: Retrofitting Two New High-Purity Water Systemsover 9 years ago
Single-Use Bioreactors Have Reached the Big Timeover 9 years ago
Parallel Processingover 9 years ago
Cost Considerations Drive Lean Technology in BiomanufacturingAdvertisement
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This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
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