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Emerging Therapies: CMO’s Tackle Biomanufacturing Challenges

Innovative cell and gene therapies and the resurgent interest in ADC’s (antibody drug conjugates) are emerging therapies that are creating these challenges. The roundtable discussion entitled; Outsourcing and Biomanufacturing Challenges for Emerging Therapies, at BIO 2016 focused on demands for CMO services associated with these therapies. Patti Seymour, Senior Consultant at BPTC moderated a panel consisting of Mark Angelino, bluebird bio; Chris Chen, WuXi Biologics; and Andreas Weiler, Lonza: three respected industrial strategic outsourcing thought leaders.

Topics addressed by the panel included forecasting the demand for CMO services and the associated issue of capacity planning. Within this context are the concerns about process design and control as well as regulatory framework related issues such as batch definition when evaluating centralized versus decentralized models for cell therapy. Another discussion point addressed the complexities of supply chain when managing four or more CMC programs per ADC product.

One approach to services planning suggested by the panel begins by sorting the preclinical and clinical pipelines in these therapeutic areas and identifying the short and long term technology implications and capacity needs. Everyone agreed these emerging therapies will represent a learning curve for CMO’s and embody a step-up in risk for both innovators and CMOs.

However, the panel agreed that allogeneic and autologous cell therapies, gene therapies with their associated viral vectors and delivery modes, and novel antibody-linker-toxin ADC combinations represent potent disease therapy options and have the potential to cure disease. These therapies are gaining traction and have great promise. BPTC has a number of client projects in all three areas and is witnessing rapid innovation within these emerging therapies.

 

Blog article by: Patti Seymour