Industry Insights

41. FDA Remote Inspections Guidance 2/8/2023

    Since the COVID-19 pandemic first hit, remote audits and inspections have been essential. Learn about remote audits and inspections and how audit management software can make the process easier.

42. A Simplified, Five-Step Approach To Applying FDA's Human Factors Guidance 4/23/2018

    FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices. 

43. Solving The Leukopak Supply Chain Issue With Cryopreservation 11/25/2024

    Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.

44. Are KRAS Inhibitors Poised To Cure Cancer? 8/21/2023

    The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.

45. Great siRNA Science Or Savvy Business Acumen? You Need Both 8/28/2024

    Silence Therapeutics has two wholly owned siRNA therapies now in clinical trials and one partnered program with AstraZeneca. Silence's CEO discusses the need for good science, making smart business decisions, and cultivating partnerships.

46. A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work 11/21/2025

    Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.

47. Using Advanced Mass Spectrometry To Analyze APIs And Impurities 3/17/2023

    Characterizing impurities through advanced analytics is a critical step in ensuring biotherapeutic product quality. Learn more about the growing role of CDMOs in developing these products.

48. Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems 4/20/2023

    While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

49. Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update 3/26/2020

    This article compares aspects of the biosimilar development pipeline and related market evolution since 2013, including what has and hasn’t changed.

50. Pandemic Prompts Supply Chain Exodus From China — What's Best For Your Business? 4/27/2020

    Decisions made in panic rarely work out for the best. In lieu of abandoning operations in China completely, consider these alternatives to secure your company’s supply chain.