Guest Columns
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The Booming Merger Of Biopharma Separation Techniques & Mass Spectrometry
7/6/2022
The evolution of modern mass spectrometry (MS) as well the hyphenation of MS to a broad range of analytical separation techniques used in biopharma development has fueled a strong development in analytical tools for physicochemical characterization.
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FDA Seeks Comment On ICH Q9(R1) Quality Risk Management
7/5/2022
ICH has revised Q9 Quality Risk Management, and it provides principles and tools for quality risk management that can be applied throughout the product life cycle of drug substances, drug products, and biological and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. Submit comments by July 15, 2022.
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Solving Bioassay Challenges for Cell & Gene Therapies
7/1/2022
Recently, USP held a bioassay training workshop that included regulatory considerations, analytical validation, and case studies related to bioassays for cell and gene therapy products that are also used for potency. This article recaps the key insights from the workshop.
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Financial Market Tumult Shows The Need For Creative Funding For Life Sciences
6/29/2022
Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?
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Mold Investigations Using Biofluorescent Particle Counting Systems
6/27/2022
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime.
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FDA Updates Guidance For Investigating OOS Test Results
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
6/22/2022
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
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Unlocking New Insights And Treatments For Genetic Eye Diseases: ADOA
6/20/2022
This article explores how ADOA (Autosomal Dominant Optic Atrophy) occurs, and why it has become a promising target for new approaches to treatment.
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FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
6/20/2022
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
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How To Navigate Drug Repurposing And Bridging Studies
6/17/2022
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.