SEPTEMBER 20208 MANUFACTURING TECHNOLOGY INSIGHTSCell and Gene therapy (CGT) has seen a substantial market expansion in recent years. But, as an emerging treatment modality, large companies can be reticent to invest in commercial scale manufacturing capacity, and smaller start-ups and biotechs often lack funding for such an endeavor. Furthermore, the existing experience and talent pool for these products is relatively shallow when compared to its older recombinant protein cousin. Whether driven by start-ups, with resource and capacity limitations or establish pharmaceutical companies looking to supplement existing manufacturing or subject matter expertise, third party contract development and manufacturing organizations (CDMO) are playing a critical role in filling these gaps.While CDMO manufacturing in all cases requires clear oversight, dedicated staff, and well-defined objectives, externalization of CGT product, specifically viral vector manufacturing, has challenges that traditional well-established large-molecule manufacturing do not. Key success criteria Factors to Consider for Successful Outsourcing in the Cell and Gene Therapy SpaceBy Jay Newman, Senior Director, CMC Recombinant and Gene Product Development and Kitty Brady, Director, Contract Development and Manufacturing Operations, CSL Behring [ASX:CSL]Kitty BradyIN MY OPINION
< Page 7 | Page 9 >