BIO From The Editor and 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. The Peril Of Analytical Methods Transfer 9/10/2024

   Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, manufacturing equipment or consumables change, and even process development personnel turnover place analytical decisions made early on under a microscope. 

4. 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.

5. Complex Protein Development: Assay Early, Assay Often 9/6/2024

   Experts from FyoniBio, SOTIO, and Vera Therapeutics weigh in with first-hand experience on the how process decisions made very early on can influence – beneficially or detrimentally – the efficiency of upstream and even downstream operations in the development of novel protein therapeutics.

6. 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.

7. 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.

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. Delivering Large Molecules To The CNS, Overcoming The Blood-Brain Barrier 8/29/2024

   Aliada Therapeutics' CSO, John Dunlop, Ph.D., explains the company's blood-brain barrier-crossing delivery platform for large molecules.

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.