Featured Bioprocessing Editorial
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4 Focus Areas To Improve AAV Production Lines
12/18/2023
AAV-vectored drugs can potentially treat population-level diseases. But biopharmaceutical companies will have to get better at producing them in bulk. Here are some areas to focus on.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture
12/13/2023
BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.
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Mapping The Biosimilar Regulatory Landscape In The Middle East
12/13/2023
Countries in the Middle East and North Africa are promising markets for biosimilar drugs, but inconsistent regulations pose a challenge. Here's an overview of regulatory structures across the region.
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How Does The GAMP 5 Second Edition Update Look One Year Later?
12/12/2023
Since ISPE published the GAMP 5 update last year, companies say the flexible approach to computerized system validation is helpful, but the new focus on critical thinking remains a challenge.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices
12/11/2023
The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.
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Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow
12/7/2023
You may have processes in place to prevent drug labeling errors, but they can still occur. Here are three common pitfalls and the eight best practices you should be employing to make sure they don't happen.
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Is Your Bioprocess Facility Truly ‘State-Of-The-Art?’
12/6/2023
Biopharmaceutical companies calling their facilities "state-of-the-art" should use the latest, most cutting-edge technologies and techniques. Many say they do that but don't really.
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FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities
12/5/2023
In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.