BIO From The Editor and Guest Columns
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Addressing The GMP Skills Shortage With Virtual Reality
2/14/2024
In the U.K., a professor at the University of Birmingham is using virtual reality (VR) to help address the growing biomanufacturing skills shortage — using virtual reality (VR).
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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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1 In 300 People In The U.S. Is Living With HIV. That’s Not Okay With Jeff Galvin.
2/12/2024
By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.
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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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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.