Supply chain concerns get attention at Cell & Gene Therapy World

Cell therapy companies large and small face challenges in securing the raw materials they need for their research and therapy production. That was the message delivered by industry veteran Amy Hines, director of Collection Network Management, Be The Match BioTherapies, at this year’s Cell & Gene Therapy World, hosted by Phacilitate last month in Miami.…

Read our review of the updated FDA guidances for gene therapy regulations

What do the new FDA guidance documents mean for the industry?

In November, the FDA released its long-awaited regenerative medicine policy framework consisting of four guidance documents; two final and two draft. The guidance documents arrive at a time of rapid growth and expansion in the commercialization of regenerative medicines and represent the FDA’s attempt to ensure safety and effectiveness of the therapies, while spurring innovation…

The future of cell therapy: challenges & solutions

One of the biggest hurdles in commercializing cell therapies is not the regulatory process, nor is it marketing a brand new, first-in-class product. Instead, many feel that the biggest challenge facing companies developing cell and gene therapies is proving to be the manufacturing process. Manufacturing CAR-T therapies presents multiple unique challenges. First, developing a personalized…