Industry Expert Q&A with Fred Miesowicz

PharmTech: What are the advantages in developing personalized immunotherapies for patients?
Miesowicz: Personalized therapies will be able to target specific disease characteristics and pinpoint disease mechanisms in a particular patient, offering the potential for greater efficacy, earlier interventions, reduced risk of off-target drug effects, adverse reactions and toxicities, and new possibilities for satisfying unmet medical needs

PharmTech: What are some of the challenges?
Miesowicz: One of the key challenges in developing personalized immunotherapies to treat cancer and chronic infectious diseases is the need for reproducible, robust, and validated manufacturing processes that are both cost efficient and compliant with regulatory requirements. Production of patient-tailored treatments on demand requires flexibility combined with stringent protocols and quality assurance/quality control measures. Additional challenges inherent in this personalized approach include the logistics and traceability of the patient’s cells, which must be collected, processed, and returned to the patient to ensure optimal viability and outcomes.

PharmTech: How do you foresee the future of patient-specific therapies affecting the production of personalized immunotherapies?
Miesowicz: Many cell-based therapies are in clinical development and progressing through the regulatory review process.  Robust, reproducible, and well-defined automated methods for producing cell-based treatments derived from patient samples will be essential if these therapies are to be manufactured efficiently and cost effectively at commercial scale. Computer-controlled devices capable of performing and integrating sample and cell processing in parallel in a closed system can achieve these goals. Automation holds the key to making a process cost efficient and reproducible from patient to patient, sample to sample, and product to product.

PharmTech: What are the biggest challenges when manufacturing personalized immunotherapies?
Miesowicz: One of the biggest challenges for autologous cell-based therapeutic approaches to be economically feasible, particularly within prevailing reimbursement philosophies, is that the manufacturing process must be optimized for cost efficiency and scalable to large patient populations. The processing of personalized therapies requires scale-out or throughput instead of traditional scale-up. Issues such as cross contamination and changeover of equipment are exacerbated when manufacturing personalized therapies. Batch testing and release become major factors as one indication could mean up to 50,000 batches to be manufactured and released per year. The automated platform we developed at Argos addresses these limitations by enabling the required traceability and robust processing of these products with electronic batch records streamlining release. Manual processing for the scale-out has limitations that are difficult to overcome, such as manpower, facility requirements, and maintenance of consistent quality of every product produced. This all translates into a high cost of goods for the product and a much slower timing for increasing capacity to meet the market demands.

Fred Miesowicz
Chief Operating Officer, Argos Therapeutics

Article DetailsPharmaceutical Technology, Vol. 39, Issue 1
Page: 70
Citation: When referring to this article, please cite it as: "Industry Expert Q&A with Fred Miesowicz," Pharmaceutical Technology, Vol 39 (1) 2015.