Cell therapies hold great promise as new medical interventions. Diseases that until recently had no treatment options can now be effectively treated or even cured using cellular medicines. Over the past decade, several autologous cell therapies have been approved, proving the efficacy of cell therapies, especially for immuno-oncology. However, autologous therapies present several challenges for both developers and patients, that allogeneic therapies could help overcome by the key benefits that they bring.
One of the big differences between autologous and allogeneic is the time that it takes to create a therapy for a patient. It can take at least 6 months for patients to get access to an autologous treatment. Their cells need to be isolated in the hospital, brought to the lab, expanded, modified, and then brought back to the hospital to be used as therapy for the patient. This process is lengthy, and for patients suffering with severe disease it may be too long. Moreover, due to immune cell exhaustion and the health of the patient, the starting material for autologous cell therapy is often suboptimal. Cells manufactured for allogeneic therapies are at the advantage here, as they are ready to use off the shelf at any time, can come from healthy donors, be fully characterized, and avoid the patient-to-patient variability that autologous therapies present.
From the practical and cost-related perspective of a patient, or a therapeutic developer, there are also some exciting upsides to allogeneic over autologous cell therapy. Generating an allogeneic product in larger batches to serve multiple patients leads to a more standardized and predictable process with a higher success rate and takes advantage of better economies of scale, dramatically reducing the cost per patient. There are some key challenges in successful large-scale manufacturing of allogeneic cell therapies. The goal is to build a controlled manufacturing process that can reliably reproduce the cell yield and quality generated in early development stages into the clinical stages, and then finally into commercial scales. It is key to start this type of thinking early to develop an effective process and to ensure availability of the required expertise and equipment to achieve GMP-compliant scaled manufacturing.
Allogeneic cell therapy comes with some novel adventures. If you are developing an allogenic cell therapy right now, you are still an early adopter. The long-term benefits of a better cost basis for your therapeutic, hopefully easier reach to patients, and better predictability and scalability, come with some short-term obstacles. Key advice is to put the best team together, either in-house or by working with an experienced partner, who can help expedite the product development process, and catch any common pitfalls. There is an exciting set of benefits waiting for anybody developing an allogeneic, and really for all of us, if you are thinking about moving in that direction.
Cellistic's technologies are purpose-built to smartly scale iPSC technology for allogeneic cell therapy development. If you'd like to explore what that could mean for your therapy, reach out to discuss your project plans or questions.