Expert Insights On Downstream Bioprocessing

31. AP Biosciences' Approach To Complex Antibody Manufacturing 12/19/2024

    The bispecific developer's vice president of antibody discovery, Jhong-Jhe You, digs into the company's approach to purification and analytics.

32. USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli 12/3/2024

    Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.

33. Research Explores Alternative To EU-Banned Triton X-100 11/20/2024

    One of the best-known viral inactivation agents is now banned in the EU. A group of scientists explored Virodex TXR-1 as a suitable alternative. Here's what they found.

34. A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS 11/8/2024

    How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?

35. Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards 10/28/2024

    A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

36. Survey Says Downstream Biomanufacturing Bottleneck Is Over 10/11/2024

    BioPlan's 21st annual survey finds that downstream processing capacity constraints are at their lowest reported in years.

37. 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.

38. 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.

39. 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.

40. 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.