In 1931, Dr. Paul Niehans injected a preparation of live cells from a parathyroid gland into a dying patient. The patient subsequently recovered and Dr. Niehans had an eureka moment that injections of living cells can have tremendous therapeutic value.
Today, there are 13 FDA-approved cellular therapies and over 10,000 clinical trials open for cell therapies. In comparison, there are approximately 3,000 trials open for antibodies. This small number of currently approved cellular therapy products verses the large number of trials raises the odds that a large gap in manufacturing capacity is imminent.
As cell therapies come to market, the industry may find a need to rapidly build commercial production facilities dedicated to these therapies over the next few years. Cell therapies present a unique set of criteria for facility needs and process economics needs that vary significantly with factors like patient population, autologous/allogeneic cell lines, and process closure.
So, what is our action here?
Low hanging fruit includes allogeneic cell therapies which can heavily leverage the work vaccine manufacturers have put into optimizing adherent cell culture designs. The challenges of handling large amounts of 2D bioreactors and automation of those processes have been addressed by various players. Expanding and improving offerings upon that backbone is realizable in the immediate future.
Small boutique fillers are available from multiple vendors to meet the needs of small batches. With those small batch sizes, a comparison should be done to determine if the increased variable cost of closed filled vials outweighs the fixed costs of traditional component preparation.
Unfortunately, autologous therapies are a different animal altogether. Making treatments for individual patients fits with a pharmacist or doctor model, in particularly, because many of these therapies are regionally hosted and time sensitive.
In this case, does this drive a process that is executed via an automated regulated medical device that a clinician uses? A Walgreens and Miltenyi Biotec partnership? Do the upcoming therapies follow a model similar to blood banks, or perhaps a new model? Maybe chains of regional manufacturing centers close coupled with regional hospital systems. Will the standardized need of that model drive a boom in pre-fabricated modular cleanrooms?
A common hurdle to both autologous and allogeneic therapies is the cold chain shipment which is time-consuming, expensive, and difficult to validate given the inherent variables and unknowns associated with postal deliveries, weather, etc. Labeling and then reading those labels on cryopreserved vials is another issue that cell banks have had to address and requires detailed planning all the way from filling the vial to clinical use.
It might make sense for autologous cell therapy operations to close coupled labeling and secondary packaging with filling where allogeneic operations may require universal primary label close coupled to filling and secondary packaging, and then handed off to a specialized third party.
Upcoming facilities dedicated for cell therapies will need to look different than current biotech facilities to meet the unique process requirements and business practices, requiring specialized architecture and engineering skill sets. The variety of processes and clinical administration practices for this group of products will drive manufacturers and engineers to find different solutions.
The large pipeline and high potential therapeutic value will send the industry scrambling for manufacturing solutions and capacity. When that time comes, we will look to take the current thinking from traditional healthcare, regional models, and biotechnology, and turn it on its side to get a fresh view, mixing and matching what works to come up with a new model that leverages the efficiencies of evolving science and an evolving economy.
(Source: IPS – Integrated Project Services, LLC)