Guest Columns & From The Editor
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A Look At siRNA & Market Trends
1/3/2024
Small interfering RNA (siRNA) is a class of molecules that play a crucial role in the regulation of gene expression. This article shares how siRNA functions as well as new market research for the field.
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Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield
1/2/2024
It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status.
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Cell & Gene: The Podcast Episodes From ARM’s 2023 MOTM
12/21/2023
All three episodes of Cell & Gene: The Podcast recorded at ARM's 2023 Meeting on the Mesa have now aired. Here's a look at my guests and the important CGT topics we discussed.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3
12/20/2023
This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.
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4 Focus Areas To Improve AAV Production Lines
12/18/2023
AAV-vectored drugs can potentially treat population-level diseases. But biopharmaceutical companies will have to get better at producing them in bulk. Here are some areas to focus on.
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iCell, Coeptis On FDA’s Investigation Of CAR T Immunotherapies
12/18/2023
Last month, the FDA stated it was investigating serious risks of T-cell malignancies in patients following treatment with a chimeric antigen receptor (CAR) T-cell therapies. I met up with Yupo Ma M.D., Ph.D. Chief Scientific Officer at iCell Gene Therapeutics, and Dave Mehalick, CEO and Colleen Delaney, M.D., Chief Scientific and Medical Officer at Coeptis Therapeutics to get their reaction to the FDA’s investigation.
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Understanding FDA's Rare Disease Therapeutics Pilot Program
12/18/2023
FDA aims to advance medical research and therapeutic solutions for rare diseases with its Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture
12/13/2023
BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.