In early April, Endpoints News published “Avoiding Cell Therapy Manufacturing Gridlocks — a Do’s and Don’ts Guide,” in which guidance by our CEO, Anthony Davies, figured prominently. (One of his many quotes is above in the header on this page.)
Below, please find the first few paragraphs of the article, followed by a link out to the full article on Endpoints.
How can developers prepare for the most vulnerable aspects of the cell therapy process? What steps are needed to demonstrate product comparability, with a rapid scale-up to manufacturing? When does it make sense to partner with a custom manufacturer and how can they help throughout the regulatory process? Developers must orchestrate a complex set of steps to move preclinical molecules through the clinic and manufacture therapies at scale – all while meeting regulatory guidelines and protecting patient safety. In this report, we will offer a guide to these issues and more, with commentary from consultants and manufacturers who have successfully navigated these waters. If you are working to bring a cell therapy to clinic, this guide is for you.
DON’T … forget that timing is everything
While small molecule and biologics manufacturing readily make drug products to stock, allogeneic cell therapies demand manufacturing facilities that can handle everything from intricate product development to the logistics required in producing these ‘off-the-shelf’ therapies. Autologous cell therapies manually process and deliver personalized, made-to-order products for each patient. Autologous therapies have a short shelf life, so developers also face unique delivery challenges — such as minimizing vein-to-vein time to safeguard the fresh product.
When strategizing treatment for autologous cell therapy patients — many of whom are battling terminal diseases — timing is everything. “Patients who are prescribed cell therapies often aren’t candidates for other drug products that are higher in the queue,” says Anthony Davies, Ph.D., founder and CEO of Dark Horse Consulting. “Right now, any length of manufacturing turnaround for these personalized medicines can mean life or death in some cases.” Planning a trial with autologous cell therapy requires mapping out a series of crucial and rapid steps with your manufacturer to optimize treatment goals for the patient, as well as overall clinical goals for the trial.