Featured Bioprocessing Editorial
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Stable Cell Lines: Stepping Stones For Continuous Viral Vector Manufacturing
2/14/2024
Amid the increasing need for greater volumes of therapeutic molecules, proteins, and viral vectors, a promising technology started to develop — the stable cell line.
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Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
2/14/2024
Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.
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Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
2/13/2024
In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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What Does The Catalent Acquisition By Novo Holdings Mean For The Biopharma Industry?
2/12/2024
Novo Holdings, the parent company to Novo Nordisk, announced a deal last week to acquire Catalent, the global CDMO, at a value of $16.5bn. In the same breath, Novo Holdings announced they will sell three sites directly to Novo Nordisk, implying that the rest of the assets of the company will continue to operate as a stand-alone CDMO. This article unpacks the acquisition, discussing questions such as “what does it mean for customers?” and “does this deal reshape the CDMO market?”
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Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity
2/8/2024
It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.
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FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
2/6/2024
Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.
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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.
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When In The Product’s Life Cycle Does Continuous Manufacturing Make Sense?
2/1/2024
This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.
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It's Time To Dethrone CHO When It Comes To mAb Production
2/1/2024
Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.