BIO From The Editor and Guest Columns
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Reprogramming Human Cells With bit.bio's Mark Kotter, M.D.
2/11/2024
The concept of programmable biology is fueling a new breed of biotech, one that requires the marriage of computational and traditional science (and both computational and traditional scientists) on the entire journey from discovery to commercial. Bit.bio is exemplary of this new breed. Its CEO, Dr. Mark Kotter doesn’t pull any punches when addressing the complexity involved in building out the company’s capabilities.
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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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3 Things You Didn’t Hear Coming Out Of JPM
2/6/2024
You’ve heard San Francisco was buzzing with cautious optimism last month. You’ve seen the M&A activity that’s buoying spirits and you know inflation and interest rates are stabilizing, if not improving. You may not have considered these three trendlines, offered by a guy who spent his time at JPM doing more listening than anything.
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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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma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In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical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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Inhalable mRNA With Ethris' Carsten Rudolph, Ph.D.
2/4/2024
Without doubt, the grand and collaborative experiment that was the mRNA COVID vaccine contributed mightily to the pandemic response and continues to save lives untold. It also demonstrated the collective power of public/private partnership in biopharma.
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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.