As we remarked in our previous blog, cell therapies are slowly coming of age, fueled by strong research and a number of therapies bravely advancing through the clinic. While confidence is increasing, there are significant hurdles before many of the therapies currently showing early clinical promise advance to mainstream status. A term that has long been thrown around to almost deafening level – “personalized medicine” – is becoming increasingly important as medicine turns to meet the needs of individual patients.
Just over one year ago, Novartis announced it had moved into the personalized T cell therapy space with CTL019 CAR therapy. Since then, the field has promptly followed suit.
Achieving a standardised, clinical and commercial-grade cell therapy product that is specific to each patient’s medical needs requires an interdisciplinary approach with innovation at every step.
Long-thought to be the main contributor to cost, raw materials are now being superseded by complex technologies, analytical systems and production requirements in the development of new personalized cell therapies.
In manufacturing, companies are turning to more inventive approaches for cost reduction.
For instance, Argos Therapeutics recently announced a partnership with Saint Goban’s Performance Plastics Division to use disposables in their manufacturing process for the production of their carcinoma immunotherapy. By doing so, Argos claims it will significantly reduce costs to off-the-shelf product levels, while allowing them to increase throughput by minimizing equipment intervention during the development of their closed-system, patient-specific immunotherapies.
While it is the belief of many that the only way for cell therapies to become competitive and self-sustaining as well as commercially viable is to develop off-the-shelf products that provide solutions specific for each human, complex needs will need increasingly smarter solutions.
Prior to manufacturing, at the development stage, new technologies have revolutionized the scientific process, from DNA sequencing to next-generation proteomics. However, the increasingly more elaborate technologies have also introduced the burden of an ever-increasing amount of data and the necessity for the interperetation, storage and analysis of this growing data pool.
Moreover, efforts are underway to establish uniform analytical protocols, which will ultimately translate to compliant manufacturing processes.
Consistent standards will be key as personalized medicine moves from research and development to data analysis.
However, the drive to develop personalized medicines has identified GMP compliance as an ever-increasing contributor to cost. Speaking to Biopharma-reporter.com recently, immatics Biotechnologies CSO Harpeet Singh stated, “GMP production is cost-intensive because of the regulatory requirements, particularly related to various in-process and post-process controls and extensive documentation.”
Once all the steps are in place and compliant processes have been established, the cost is already extremely high, even before the manufacturing stage has reached.
At that point the scientific burden is reduced, but another one altogether follows: how to keep costs of production down. Outsourcing vs. in-house production, raw materials, efficient processes (disposable vs. reusable), are considerations that are going to grow are cell therapies reach maturation.
Akron Biotech has been at the forefront of new initiatives by participating in Whitepapers regarding ancillary materials with ISCT and other regulatory standardization activities through the Alliance of Regenerative Medicine. The objective of such initiatives is to achieve compliant quality standards and cost effective options in ancillary materials used in advanced cell therapies.
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