Guest Columns

1. 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.

2. 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.

3. 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.

4. 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.

5. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR 9/4/2024

   Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy?

6. EMA Issues New Draft Guideline: Chemistry Of Active Substances 9/3/2024

   The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

7. August 2024 — CDMO Opportunities And Threats Report 9/3/2024

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

8. 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.

9. 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.

10. Luxturna Maker Spark Therapeutics' Flexible Platform Approach 8/28/2024

    The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.