Guest Columns
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The Growing Demand And Applications For HPLC
6/6/2024
High-performance liquid chromatography offers more features compared to other analytical techniques, and the industry is finding more valuable ways to use it.
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Balanced Sourcing Of Custom Media/Buffer Formulations, Part 2: The Case For Insourcing
6/6/2024
In part 1 of this 2-part series, the authors discussed the case for outsourcing of custom media/buffer formulations. In this article, they discuss key considerations in the case for vertical integration, or insourcing.
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Are Annex 1's CCS Requirements Still Challenging You?
6/5/2024
Contamination control strategies are nothing new, but their inclusion in the Annex 1 update represents one of the revision's few new requirements.
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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.