From The Editor

31. Suppliers Pushing Novel Analytical Methods Testing Forward 10/17/2024

    The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?

32. Tune Therapeutics On Clinical Readiness, Technology Adoption 10/16/2024

    Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

33. Discovery vs. Hypothesis-Driven Cell Line Development 10/8/2024

    Susan Sharfstein, Ph.D., explains how discovery-driven research can further our understanding of cellular biology and ultimately inform cell line development.

34. How Platform Technologies Are Shaping The Gene Therapy Landscape 9/30/2024

    Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.

35. Gene Therapy CMC Experts On Late-Stage Process Changes 9/27/2024

    At the 2024 Bioprocessing Summit, a panel of CMC experts spoke about the challenges commercializing gene therapies, specifically focusing on considerations for late-stage process changes.

36. Outsourced Complex Protein Development Demands Special Considerations 9/20/2024

    Complex protein therapeutic innovators are often orchestrating the work of three, four, or more outsourced manufacturing partners at once. What goes into their selection criteria? Experts from ADC and fusion protein sponsors weigh in, with bonus commentary from a CDMO process development specialist.

37. Considerations For AI Use In Biomanufacturing 9/18/2024

    Expert's from this month's Bioprocess Online Live event discuss different use cases for AI and shared their thoughts on the adoption of these technologies. 

38. 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. 

39. 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.

40. 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.