Excellent scientific talks and great weather were on tap when I attended the 2017 Cell & Gene Therapy World in Miami in January. Ed Field from BioRestorative Therapies started off with the top events of 2016, which was populated with some sizable deals.
This suggests cell and gene therapy continues to attract investment, and that expectations for approved products will be met very soon, perhaps in 2017. This set the tone for an exciting and productive meeting, as companies and academic institutions both continue to push the envelope in manufacturing.
Several companies showed data using the iCellis Bioreactor from Pall Corporation and the yields are impressive. CEVEC continues to develop its CAP-GT cell line for viral vector production, showing improved performance. Some companies are pursuing stable cell lines, showing the importance of raw materials and cell substrates in gene therapy manufacturing.
Strategies and control
At the event, I was a member of the manufacturing section, "Adapting to increased emphasis on traceability, transparency and control of starting and raw materials". Our panel discussion, "Raw materials as a critical component of your business strategy", was a great learning experience for participants and audience alike.
Dr. Dominic Clarke from Charter Medical Ltd. chaired the session and facilitated conversation about several important topics. Marlin Frechette from Irvine Scientific and Jeremy Kolenbrander of Terumo BCT both gave engaging presentations on what they are seeing from clients and regulatory authorities concerning raw materials. They were joined on the panel by Dr. Knut Niss from Biogen and me.
Analytics and CMOs
One of the conclusions from the discussion was the importance of analytics. Choosing the proper quality control assays with relevant specifications can make or break your production runs. I discussed the advantage of Aldevron's different quality grades, from research through clinical and commercial, is that the assays are consistent and specifications are met at all quality levels.
Joe Hughes from Wuxi was in the audience and mentioned the importance of CMOs in the supply chain working with other manufacturers on assay development. In many cases, the CMO that produces the API must perform QC tests on raw materials, and it is important for the CMO and the supplier to share information on assay procedures and specifications.
Thanks to all the clients who stopped by the booth. Tanner Dockendorf, Ally Hauser and I enjoyed many productive conversations. See you in 2018 back in Miami!