From The Editor

31. 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.

32. 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.

33. 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. 

34. 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. 

35. 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.

36. 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.

37. 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.

38. The ADC Market Is Ripening For Disruption 8/21/2024

    Where there is therapeutic demand, the industry will build capacity. But with ADCs, cytotoxic payloads and a fragmented contract manufacturing landscape make the path to clinical and commercial supply dauntingly complicated. Here's how the ADC manufacturing market is shaping up, and how it might ultimately shake out.

39. Are You Taking The HPCs In Your ADCs Seriously? 8/16/2024

    The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.

40. Are Bioprocess Equipment Standards A One-Sided Conversation? 7/31/2024

    Half of respondents to a recent survey of biopharmaceutical companies said the greatest challenge in further growing industry acceptance of single-use technology—which now comprises an eye-popping 85% of non-commercial-scale biopharma manufacturing infrastructure—is the greater challenge in further growing industry acceptance of single-use technology