In an interview published in the May 2017 issue of Drug Development & Delivery, PCT President Robert Preti, PhD, discusses PCT’s founding, differentiators, growth, and vision for the future. Following is an excerpt from that interview:
Q: How will cell therapy manufacturing processes need to evolve in the coming years to make cell therapies commercially viable?
A: To achieve optimal DbD-based manufacturing, particularly for patient-specific cell therapies, the industry needs not only manufacturing processes that are vastly different from the traditional methods of manufacturing biologics, but also ones that are vastly different from even the current standard of cell therapy manufacturing. In order for the cell therapy industry as a whole to truly become commercially viable, we must envision and develop the “factory of the future.”
What does that look like? Ideally it is a manufacturing facility in which processes are in controlled, non-classified (CNC) spaces, with concurrent adjacent processing of patient lots. This leads to a highly mitigated risk of both human error and of cost impact due to idle capacity. An ideal facility will also have a robust, secure supply chain, a minimal set of unit operations to execute the process, and a very low failure-to-deliver-therapy rate. Cell therapy manufacturing must move largely away from the cleanroom model and be sent to the “back of the facility,” into production spaces more suited to high-volume production as described.
That is not to say that cleanrooms have no place in cell therapy; they certainly do — at least for now. However, any time that automation, integration, and closed processing systems can result in steps whereby one entire cleanroom need not be dedicated to one process for one patient at a time, your bottom line will likely be in better shape for the effort
Q: What should cell therapy developers keep in mind as they choose a contract manufacturing partner?
A: Cell therapy developers should thoroughly investigate the candidates when transferring from an in-house facility or partner (such as an academic center) to a manufacturing partner. They should look at technical expertise (Do they have experience with my specific cell type, with specific manipulations and with manufacturing development? Do they offer a broad range of technology solutions? Are they simply playing a “me too” game?); experience (What manufacturing challenges have they overcome for their clients? Do they have the experience and facilities required to meet all FDA standards?); and the process of collaboration (Are they willing to be flexible? Is there a twoway flow of communication?).
What cell therapy developers need in a partner is an organization willing to think outside the box while meeting established phase-appropriate quality standards, offer custom solutions, and find improvements which can be integrated at the right times over the course of clinical development to make their process more efficient, more cost effective, and more sustainable. A developer and its manufacturing partner should share the goal of bringing their cell-based therapy to market with a manufacturing process that best positions the product for long-term commercial success.
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