Featured Articles

  • Changes: A turbulent year for FDA oversight

    Friday, January 02, 2026
    Characterizing 2025 from a regulatory perspective is uniquely challenging. Perhaps David Bowie said it best when he said, “I don’t know where I’m going from here, but I promise it won’t be boring.” read more

  • Ensuring viral safety in advanced therapies

    Wednesday, October 15, 2025
    Viral clearance studies, long a cornerstone of biologics production, are now being reevaluated and adapted for genetically engineered viral vectors and vector-derived products. read more

  • How digital can ease the burden of cell and gene therapy long-term follow-up

    Wednesday, September 17, 2025
    Because CGTs are designed to have lasting and lifelong effects, regulatory bodies often mandate 15-year, long-term follow-up. Fortunately, collaborative groups are creating resources and recommendations for these emerging studies. read more

  • Rethinking iPSC development

    Wednesday, September 10, 2025
    A robust CMC strategy cannot be retrofitted; it should guide decisions from the very beginning. For developers aiming to bring iPSC-based therapies to the commercial market, the starting point is not the laboratory bench, it is the ... read more

  • Navigating cell therapy's maze of risks

    Wednesday, September 03, 2025
    Biopharma companies advancing cell therapies must confront a range of key considerations and risks. A strategic, collaborative approach can accelerate development and ensure patients reliably access safe and effective cell therapy products. read more

  • Are LNPs the new AAV?

    Wednesday, August 27, 2025
    The emergence of nonviral vectors represents an opportunity to propel in vivo gene therapy further into commercial adoption and expand its impact globally. LNPs are poised to become the first commercially approved nonviral vectors for in ... read more

  • Navigating the realities of CAR-T cell oncology trials

    Wednesday, August 20, 2025
    Given the undeniably novel aspect of this new paradigm, however, conducting CAR-T clinical trials presents a unique set of obstacles for sponsors, sites and regulators to carefully navigate. Moreover, the complexity of manufacturing, ... read more

  • Ferring debuts U.S. facility to tackle manufacturing bottlenecks

    Wednesday, August 13, 2025
    Ferring has spared little expense in its efforts to get Adstiladrin to patients, including nearly $500 million in manufacturing investments. read more

  • Cellular rebirth

    Wednesday, August 06, 2025
    After decades of research that hadn’t translated into efficacy in patients and a proliferation of unsubstantiated stem cell science, MSCs seemed stuck in therapeutic purgatory, unable to rise from the pyre and prove their validity. read more

  • MSCs rising

    Wednesday, July 30, 2025
    With MSCs back in the spotlight and a pipeline of mid- and late-stage candidates pushing toward regulatory submission, what looms now is not a question of whether MSCs can deliver, but the challenge of turning decades of insights and ... read more

  • CGT innovation under pressure

    Wednesday, July 23, 2025
    In 2025, a new challenge has taken center stage: A tightening macroeconomic environment that threatens to slow the pace of innovation. read more

  • The state of CAR-T therapy manufacturing

    Wednesday, July 02, 2025
    Emerging cell types are broadening the treatment scope of cell therapy, while automation, PAT and strategic partnerships are addressing manufacturing challenges. Emphasizing the safety of these therapies will improve accessibility and build... read more
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