Featured Bioprocessing Editorial
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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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma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In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical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.
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Novel Approaches For Obtaining High-productivity Clones
1/30/2024
Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.
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Factors To Consider When Licensing An ADC Program
1/30/2024
Elevation Oncology's CEO and CSO explain what made the company's lead ADC candidate, EO-3021, worth licensing from Chinese pharmaceutical company, CSPC.
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Relational Risk Analysis For The Bio/Pharma Industry
1/29/2024
Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.
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Tangential Flow Filtration 101 — The Tech, The Need, And The Market
1/26/2024
Here's a high-level summary of what is increasingly becoming an essential part of the downstream bioprocessing production line.
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Picking The Best Virus Sample Prep Method In Process Development
1/26/2024
Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.