Issue link: https://www.e-digitaleditions.com/i/1468049
18 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Biologics Durdy, CEO, Cell and Gene Therapy Catapult; Matthew Hewitt, executive director scientific ser- vices, cell and gene therapy, Charles River; Emily Moran, vice president, viral vector manufacturing, The Center for Breakthrough Medicines; Chris Xu, CEO, Thermogenesis; and David Chang, CEO of WuXi ATU about challenges, breakthroughs, and trends in manufacturing CGTs. Manufacturing challenges for CGT PharmTech: What are the biggest challenges for manufacturing CGTs? Meurer (Biopharma Excellence): One of the seri- ous challenges is the affordability of cell and gene therapies for the healthcare system and for patients. Manufacturing costs often contribute significantly to the high price, although continu- ous efforts are being made to reduce these costs via improved manufacturing technology. Typi- cal reasons for high manufacturing costs are the need for f lexibility in the manufacturing sched- ule, scale limitations, expensive quality control, and complex logistics. Durdy (Cell and Gene Therapy Catapult): We need to look at [the] manufacturing of CGTs in the full context of what it takes to deliver [the] manufac- turing of these therapies in order to identify key challenges. Skills, supply chain issues, and access to f lexible manufacturing capacity to meet patient and clinical timelines, as well as automation/digi- tization of documentation for batch release are some of the challenges that need to be addressed to enable these therapies to reach patients in an efficient way and at scale. Hewitt (Charles River): A pain point more relevant for autologous cell therapies is how to efficiently manufacture them to minimize vein-to-vein times. Currently, companies are employing a centralized manufacturing approach, which is possible in the short term as the current slate of commercial therapies addresses small patient populations. Even so, there have been issues with this current model. A 2021 European Hematol- ogy Association conference poster described how vein-to-vein times can vary significantly when commercial cell therapies are manufactured far from the point of care (1). From this, a question arises whether autologous cell therapy manufac- turing needs to migrate to a decentralized manu- facturing model to reduce vein-to-vein times. Moran (The Center for Break-through Medicines): Current therapeutic platforms are nascent, de- veloped in academic labs, challenged by the abil- ity to efficiently scale, replicate, and effectively manufacture their therapies. While the science behind these platforms will need to change over time, regulators need to keep pace. Close col- laboration with regulators is required to develop a path to approval. Manufacturing solutions for advanced therapies require seamless and robust tech transfer processes to avoid delays in process development and inefficient scale-up models; this is a current gap that needs to be addressed. Xu (Thermogenesis): The process is very lengthy with storage and harvesting having to yield to certain standards. There are not a lot of CDMOs [contract development and manufacturing orga- nizations] that are well-equipped to handle the process that is required for cell and gene therapy manufacturing, and it takes years for a company to build their own, shall we say, formula of manu- facturing. This leads to a shortage of CDMOs. Chang (WuXi ATU): One of the biggest challenges still facing the cell and gene therapy industry is