Viral clearance studies, long a cornerstone of biologics production, are now being reevaluated and adapted for genetically engineered viral vectors and vector-derived products.
Wednesday, October 15, 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.
Wednesday, September 17, 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 strategic plan.
Wednesday, September 10, 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.
Wednesday, September 03, 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 vivo transgene delivery and genome editing approaches.
Wednesday, August 27, 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, delivering and managing genetically modified cells has made CAR-T ...
Wednesday, August 20, 2025
Ferring has spared little expense in its efforts to get Adstiladrin to patients, including nearly $500 million in manufacturing investments.
Wednesday, August 13, 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.
Wednesday, August 06, 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 technology advancements into the next generation of commercialized...
In 2025, a new challenge has taken center stage: A tightening macroeconomic environment that threatens to slow the pace of innovation.