Addressing Key Challenges in Cell and Gene Therapy Manufacturing
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Cell and gene therapies offer potential treatment avenues for a number of diseases, including genetic disorders and cancer, which otherwise face limited options. Recent advancements in gene editing and cell culturing have brought such therapies to the forefront of modern medicine; however, there are still challenges that must be conquered before they are readily available for patients on a large scale.
The manufacturing of cell and gene therapies is a complex, time-consuming process and must be conducted under strict regulations to achieve compliance requirements. This can ultimately delay the process through which life-saving treatments are delivered to patients. Thermo Fisher Scientific recently announced the launch of a product, compliance, and service portfolio, known as the Thermo Scientific Cell Therapy Systems (CTS) Series Laboratory Equipment, which is compatible with current Good Manufacturing Practice (GMP) and aims to help the rapid start-up of cell and gene therapy manufacturing, both in clinical and commercial contexts.
Technology Networks spoke with Hugh H. Tansey, senior director of innovation and growth programs for laboratory equipment at Thermo Fisher Scientific to learn more about how the CTS Series Laboratory Equipment can deliver solutions for the key challenges in cell and gene therapy manufacturing. Tansey also discussed the current state of play in cell and gene therapy research, and his expectations for the future of this field.
Molly Campbell (MC): Which disease areas are set to benefit the most from cell and gene-based therapeutics?
Hugh H. Tansey (HHT): Applications where cell therapies are in development include oncology, musculoskeletal, autoimmunity and dermatology. Currently, the application receiving the most attention – and funding and development – is in oncology, with the advent and approvals of therapies for cancer immunotherapies such as CAR-T cell therapy. Another great benefit of this technology is treatments for “orphan” diseases which previously had no other therapy, such as sickle cell anemia.
MC: Cell and gene therapy manufacturing is a complex process. What are the key challenges in this space?
HHT: With a complex and long process including over 300 steps, autologous cancer immunotherapies have challenges in process and protocol, in addition to the variability of the patient state, T cell activity and purity, and growth of the cells in culture. The process and conditions determine variability and quality of the final product.
MC: Can you discuss the rationale behind developing the CTS Series? How has it been created to comply with GMP?
HHT: The CTS Series Laboratory Equipment was developed in response to consistent customer feedback as they face the challenges we mentioned above. Scientists, project managers and process engineers are looking for ways to improve quality and decrease the time and cost to produce these sophisticated cancer immunotherapies. They look to our equipment as proven, high quality and reliable solutions. We have responded by introducing the CTS Series Laboratory Equipment, which focuses on the core equipment developers need, and provides them with better GMP test information and documentation, in addition to comprehensive qualification compliance services, such as design qualification (DQ), installation qualification (IQ) and operation qualification (OQ) as well as services in support of performance qualification (PQ).
MC: What laboratory equipment does the CTS Series comprise?
HHT: The CTS Series Laboratory Equipment has launched with four important core products in the cell therapy market, including our Thermo ScientificTM FormaTM Steri-CultTM CO2 Incubator, Thermo ScientificTM HerasafeTM 2030i Biological Safety Cabinet, Thermo ScientificTM GP PRO4R centrifuges and Thermo ScientificTM CryomedTM Controlled Rate Freezer. All of these products offer proven performance, reliability and features ideal for working to GMP standards, and are now packaged with a comprehensive factory acceptance test [FAT] document binder. They can also be packaged with complete field IQ & OQ compliance services.
MC: How will the CTS Series simplify and optimize cell and gene therapy manufacturing?
HHT: Scientists, process engineers and project managers are looking for ways to get their production of immunotherapies, gene therapies and cell therapies up and running faster, with reliability and proven operation, and keep them in compliance. The costs of getting through the DQ, IQ, OQ and PQ process and achieving start-up, in many cases are more than the equipment itself – sometimes much more. The ability to efficiently and effectively begin operations under GMP conditions is of paramount importance in this dynamic and variable field of regenerative medicine.
MC: Are you able to discuss any specific examples of scientists that are adopting the CTS Series?
HHT: We are working with a significant number of the institutes that are emerging in this field and conducting clinical trials. They come to us for proven, innovative technologies. For example, the very delicate and precise cell culture conditions established in our Steri-CultTM CO2 incubator used in the highly critical step of cell growth and expansion to create the volumes of T cells needed for therapeutic infusions to beat lymphoma and leukemia. Other examples include treatments for irritable bowel diseases, regeneration of skin for burn and trauma patients, muscle replacement for loss of smooth muscle function, and developing gene therapies for eye diseases.
MC: In your opinion, how will cell and gene therapy manufacturing advance in years to come? How will the CTS Series support this?
HHT: We plan to continuously expand our offering in the CTS Series Laboratory Equipment as the market segment develops, with attention to GMP needs, such as documentation, workflow integration and services. The state of cell and gene therapy is highly dynamic and in continuous search for improvements in quality, cost, therapy duration and with trends toward closed, single use consumables, automation, improved analytics and workflow integration. Our commitment with the CTS Series Laboratory Equipment is to serve as a reliable, responsive partner in these rapidly changing landscapes for developing world-changing new therapies.
Hugh H. Tansey was speaking to Molly Campbell, Science Writer for Technology Networks.