BIO From The Editor and Guest Columns

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

    Experts from FyoniBio, SOTIO, and Vera Therapeutics weigh in with first-hand experience on 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

38. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield 8/27/2024

    This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

39. Key Takeaways From The 2024 Bioprocessing Summit 8/26/2024

    Editor Tyler Menichiello reflects on the topics and trends covered at this year's Bioprocessing Summit in Boston.

40. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.