In recent years, the pharmaceutical industry has shown a growing interest in allogeneic cell therapy (CT). While autologous CT will remain the go-to solution in the near term for the development of personalized cancer therapeutics using chimeric-antigen receptor T (CAR-T) cells, the advantages of allogeneic CT for this and other applications cannot be denied, and market trends
Allogeneic CTs are engineered for specific therapeutic applications in any patient and can be produced uniformly, at scale, in a quality-controlled environment. This offers the patient fewer procedures and lower costs, the physician and patient access to readily available treatments, and the pharmaceutical firm a predictable, streamlined production process. These factors make allogeneic cells the future of low-cost cell therapy.
Allogeneic Cell Therapy: Opportunities and Hurdles
The development of allogeneic cell therapies faces two primary impediments that challenge its widespread application. First, the nature of biology creates significant hurdles. Engineering a cell type in a way that it can be transplanted into a recipient without triggering an immune response is an extremely difficult task. Second, achieving consistent quality results from one batch of cells to another is a complicated process. Variability in manufacturing processes, environmental conditions, and donor characteristics can impact the final product.
With production scales rarely exceeding 50 L, there are ambitious aspirations to expand beyond this limit, but the necessary knowledge and technology are not generally widespread and available within the industry at the moment. However, finding an outsourcing partner that is testing how these therapies can be scaled and expanded to larger capacities is something every developer should consider. For example, our teams at AGC Biologics have experience with the production of several batches in parallel at a 50 L scale, and are continuing to explore future opportunities for these therapies. This type of scientific expertise and innovation can offer exceptional value to customers seeking a partner that is able to use all resources available to create innovations for allogeneic CT projects.
Outsourcing Allogeneic CT Development and Manufacturing
Pharmaceutical firms wishing to streamline an existing CT development pipeline, or to derisk their entry into allogeneic CT, require a partner who specializes in cell therapy products.
A contract development and manufacturing organization (CDMO) can provide this specialty support, accelerating the process of allogeneic CT development and therapeutics manufacturing. CDMOs offer the infrastructure and expertise that would be impractical or uneconomical for pharma companies to quickly acquire.
However, it is important to take care when choosing a CDMO. Not all CDMOs have experience in diverse cell lines, not all provide the flexibility to accommodate clients at various stages of development or with specialty needs, and few are experts in the development of cell and gene therapies (C>).
AGC Biologics offers unparalleled support, with flexible, cost-effective offerings that span every stage of development, from pre-clinical to commercialization, and all the way through fill and finish. With 30 years’ CDMO experience, we have brought 3 commercial cell therapies to market, supplied over 30 cell and gene therapy trials in the European Union and the United States, and our work has treated more than 500 patients globally in need of custom cell therapy programs.
Our Milan, Italy facility was the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies. Our experts here can work with virtually any cell type, and can perform transduction with lentiviral, retroviral, and adeno‐associated viral vectors. This site’s scientists have several decades of industry experience, with industry-leading expertise in process development (PD) and internalizing client autologous and allogeneic processes.
Scientists at our Longmont, Colorado location have a 20+ year track record working with complex cell therapy. Capabilities include viral vector development, characterization, and manufacturing in adherent and suspension environments. This facility employs the latest methodologies for the culture and modification of cells, from development to manufacturing. The Longmont campus just completed construction and qualification of multiple new cell therapy suites to help expand this site’s growing capabilities.
At each site we use customization, development, qualification, and validation activities for manufacturing and analytics. AGC Biologics also follows a GMP-like process in our process development steps, helping developers derisk the transfer to GMP stage. We operate multiple Class B and Class C suites for cell therapy, and work with the latest technologies to ensure the best possible results.
AGC has proven expertise in cell engineering, experience receiving and working on fresh or frozen cells, and familiarity with T and NK cells, as well as CD34+ hematopoietic stem cells. Our partnership with RoosterBio allows us to provide the best cell media possible. Plus, we perform more than 160 analytical tests in-house to ensure quality, sterility, viability, and potency – and to reduce overall turnaround time for clients. We are at the forefront of the newest processes and cell types in the industry, with particular expertise in exosome development, a growing field of innovation in advanced therapy medicinal products (ATMPs).
Our services support CT developers through every stage of the pipeline, including tech transfer, process development, cell culture, cell modification, GMP manufacturing, QA/QC, and fill and finish. We can transfer client processes at any development phase, from R&D to cGMP. We also provide support for regulatory submissions, including IND, IMPD, BLA, and MAA.
Taken together, that means a fast, efficient, cost-effective process that meets the changing market needs for emerging allogeneic CT products.
It’s Time to Accelerate Cell Therapy
An opportunity now exists to revolutionize treatment of diseases that many of us will have in our lifetimes. Allogeneic CT has the potential to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.
AGC is at the forefront of this space, developing and manufacturing allogeneic CT products side-by-side with our clients. If you need help bringing a CT product to market, or you’d like to see our offerings, click below to learn more.