Guest Columns
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Strategies To Address FDA CMC Trends For mRNA Therapies
9/24/2024
A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.
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Araris Doubles Down With Dual-payload ADC
9/24/2024
Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.
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5 Strategic Advantages Of Manufacturing ADCs In-house
9/20/2024
Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.
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Accelerate CMC Development With Team Topologies
9/20/2024
A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.
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Upping Flow Of Advanced Technologies Into Commercial Biomanufacturing
9/12/2024
A set of tools NASA developed assessing new, rapidly developed and deployed technology could help biopharmas adopt advanced tech post-commercialization.
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FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
9/11/2024
The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.
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How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies
9/10/2024
This article discusses how cell and gene therapy companies can use prior knowledge and platforms to leverage process characterization to reduce the testing and/or studies required during process validation for drug substance and drug product manufacturing processes.
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Wish SUS Cost Less? Survey Says Your Peers Do, Too
9/6/2024
BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
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A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
8/30/2024
Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.
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Capacity, AI Driving Single-use Bioprocess Probe And Sensor Uptake
8/30/2024
Disposable probes and sensors offer advantages over their reusable counterparts, especially as industry moves toward flexible, scalable production models.