Guest Columns
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A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
4/19/2024
Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
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Developing A Process Performance Qualification Master Plan For Gene Therapies
4/19/2024
This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
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The EU’s Ban On TiO2 In Food May Impact Pharma. Here’s What You Should Know.
4/18/2024
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
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What Time Is Best To Bring My CDMO On Board?
4/17/2024
The answer might be sooner than you think and entail more transparency than you're used to.
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Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
4/17/2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
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Michigan No Longer A Safe Haven For Pharmaceutical Companies?
4/17/2024
A recent change to Michigan's product liability law could have national implications. Experts at Sidley Austin detail the changes in Michigan, and explain what it could mean for pharmaceutical companies marketing products in Michigan and beyond.
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Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.
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Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
4/12/2024
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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AI Is Unearthing New Drug Candidates, But It Still Needs Human Oversight
4/11/2024
AI can accelerate timetables and minimize wasted resources by analyzing vast amounts of data, but human oversight is necessary to address the limitations and biases of AI systems.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.