Guest Columns
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Tackling 3 Challenges In Developing An Inhaled Gene Therapy
1/5/2024
Inhalers hold great potential for delivery of high concentrations of gene therapy directly into the lung. This article shares the experiences of a team who have worked on the development of a gene therapy to treat cystic fibrosis.
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How To Use Precipitation, Not Protein A Chromatography, For mAb Capture
1/4/2024
Protein A chromatography is a key bottleneck in mAb manufacturing. Precipitation, an early separation technique, has emerged as a ready solution for continuous manufacturing.
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Cryo-Shippers: Challenges, Controls, And Logistics
1/3/2024
Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.
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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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AI's Role In Drug Discovery To Propel Personalized, Patient-Centric Medicine
12/20/2023
AI-driven drug discovery and development represents a future where new medicines could become more precise and effective, better tolerated, and better tailored to an individual. This article shares an overview of how AI can help in this, and how can we work in a more active way toward this future.
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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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To Thrive In A Highly Regulated Manufacturing Environment, Improve Your Flexibility
12/19/2023
It sounds counterintuitive. After all, industry must put (often rigid) rules into place to govern manufacturing processes and ultimately protect the integrity, efficacy, and safety of products. But by adopting process discipline to become more agile, you'll be able to respond to changes more quickly.
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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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4 Strategies To Formulate Poorly Soluble APIs
12/18/2023
One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. This article examines four notable strategies.