Featured Editorial

31. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

32. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders. 

33. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

    This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

34. 5 Strategic Advantages Of Manufacturing ADCs In-house 9/20/2024

    Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.

35. When Should You Select Your Supply Partner? 9/19/2024

    In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

36. If The CDMO Shoe Fits, Wear It Now 9/16/2024

    Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

37. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

    How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

38. A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries 8/30/2024

    To find suppliers and partners for our clinical trial programs, we need to go beyond just selecting the best offer and then managing them. For virtual organizations in particular, we must strive to be the partner of choice. 

39. Luxturna Maker Spark Therapeutics' Flexible Platform Approach 8/28/2024

    The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.

40. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.