BIO From The Editor and Guest Columns
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AI Integration In Drug Manufacturing: GMP Insights For Operational Excellence, Regulatory Compliance
6/4/2024
This article provides insights into a variety of use cases on the application of AI/ML in GMP settings and 5 key considerations for drug manufacturers using AI.
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New Guide Tackles Best Practices For Making Allogeneic Cell Therapies
6/3/2024
The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.
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Is Your Intellectual Property Safe With Indian CROs And CDMOs?
6/3/2024
Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.
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Defining And Overcoming Batch Release Deviations
5/31/2024
Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.
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Sorting Through Winners And Losers Of New Technology In Pharma
5/30/2024
Innovation and improvement are often used synonymously, but sometimes innovation hinders more than helps. Here’s a cold-eyed look at recent blockbuster tech advances.
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Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing
5/29/2024
Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.
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EMA Updates Guidance On Inhalation And Nasal Product Quality
5/29/2024
The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.
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FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
5/24/2024
This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.
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Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products
5/23/2024
FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.
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Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?
5/21/2024
Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.