Guest Columns

41. Rethinking Cell Therapy Durability: Transient, Non-genetic, Changes To Cell Function Could Be Key To Broader Patient Impact 3/16/2022

    As we consider the future of cell and gene therapies, strategies that leverage transient cell alterations to enable a durable benefit can be a major driver of patient impact.

42. Key Considerations For cGMP Building Conversions 3/16/2022

    As the life sciences workforce has increased, companies need more space to accommodate them. One emerging option is searching for buildings such as offices and warehouses and converting them into biopharma manufacturing facilities. However, not all conversion projects are as easy as you would hope. This article shares key considerations for such a project.

43. The 13-Step Guide For Conducting Cell & Gene Therapy EHS Risk Assessments 3/14/2022

    One of the hurdles for cell and gene therapy manufacturers is the lack of health and safety guidelines. This article summarizes the main steps in a suggested EHS risk assessment process. It can form the basis for discussions between a contract manufacturer and client or between production and development departments. What could go wrong?

44. Biopharma Deal-Making In 2022: Key Trends 3/11/2022

    Strategic partnerships and alliances in biopharma have become an even more important means of accessing new capabilities. This article examines key recent trends in biopharma deal-making and M&A, and how those will inform related activities in 2022.

45. Biosimilar Interchangeability: Regulatory & Practical Considerations 3/9/2022

    Biosimilar interchangeability refers to the possibility of exchanging the reference biological product with its biosimilar (or vice versa) or exchanging biosimilars of the same reference product. This article provides an up-to-date overview of regulatory and practical considerations regarding biosimilar interchangeability with an emphasis on the European perspective.

46. What’s All The Hype About mRNA Vaccinology? 3/7/2022

    The COVID-19 mRNA-based vaccine success is spurring a further stream of medicines to come. This article provides an overview of mRNA for those who aren't already working in the field, how mRNA is being used in vaccines, and how mRNA can be used for future developments.

47. Single-Use Technologies: A Game Changer For Expanding mAb Production 3/4/2022

    A biotech company that this author worked with had an expanding pipeline and needed to increase its manufacturing capacity, so single-use technologies were implemented from media prep through buff prep, to seed train and through the downstream process. The company saw a dramatic reduction of production costs.

48. Advanced Therapies: Industry, Regulators Share Perspectives 3/2/2022

    USP, in collaboration with South Korea’s National Institute of Food and Drug Safety Evaluation​, hosted a Joint Workshop on Advanced Therapies​. This article recaps the discussions, including regulatory and quality control perspectives on raw materials, manufacturing considerations for advanced therapies, and comparability plans.

49. What’s The Role Of Intuition When Making QRM Decisions? 2/28/2022

    In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.

50. 6 Tips To Ensure Your NDA/BLA Is Ready For FDA Review 2/25/2022

    When preparing a marketing authorization application for an NDA or a BLA, one aspect that is easily overlooked by small start-ups and mature multi-product drug sponsors alike is verification that all commitments made to the FDA have been completed and that evidence of this has been submitted to the agency.