Cell and gene therapies hold tremendous curative potential for the treatment of devastating diseases, such as Parkinson’s disease, Type 1 diabetes, and various cancers. Besides demonstrating the safety and efficacy of these therapies, it is important to establish robust, reliable, and scalable manufacturing processes to commercialize these therapies and meet the demand to treat large numbers of patients. Here, we introduce some of the bioprocessing best practices required to de-risk the commercial manufacturing of cell and gene therapies.
Lonza has established a standard step-by-step, late-stage development approach to address product life cycle requirements and commercialization readiness, including process improvements, process characterization, and assay validation. A failure mode and effects analysis (FMEA) can be utilized to identify modes of failure, risks, and mitigations, and to design appropriate process characterization studies prior to process validation. Appropriate process improvement studies may be needed to implement innovative technologies with proper in process control and to monitor analytical methods to ensure robustness and reproducibility of the manufacturing process. It may be necessary to eliminate open and variable manual unit operations while incorporating comprehensive characterization assays to verify long-term stability of the products. The implementation of an automated, scalable, computer-controlled 3D bioreactor with appropriate downstream processing technologies would be critical to minimize commercialization risks and produce high quality products. In this webinar, we will discuss how we have applied our unique approach to support the industrialization of cell and gene therapies using pluripotent stem cells and T cells.
- Understand the types of challenges associated with the commercialization of cell and gene therapies
- Find out the principles of commercialization readiness, logical steps, and the best practices to address them in PD
- Learn about FMEA and how to use it for commercialization readiness
- Understand the best time to implement automation and minimize the commercialization risks
- Learn the key requirements for analytical methods used in the commercial processes
Dr Behnam Ahmadian Baghbaderani
Global Head of Process Development, Cell & Gene Technologies, Lonza
Dr. Baghbaderani is the global head of Process Development, Cell and Gene Technologies at Lonza. He has over 15 years of experience in stem cells engineering, bioprocessing, and cell and gene therapy (Cell & Gene Therapy) field. Dr. Baghbaderani holds a PhD degree in Biomedical Engineering from the University of Calgary (Calgary, Canada), where he developed bioreactor protocols for large-scale expansion of human neural stem cells for clinical applications. He completed nearly three years of postdoctoral program including a two-year postdoctoral fellowship at the National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS). His postdoctoral research at the NIH focused on generation of human induced pluripotent stem cells, bioprocessing of both human embryonic stem cells and human iPSCs and controlled differentiation into neuronal lineage. Since joining Lonza in 2011, he led a group of scientists at Lonza process development team, establishing pluripotent stem cells platform technologies and a cGMP compliant manufacturing process for human induced pluripotent stem cells. Dr. Baghbaderani then led the cell therapy development department (including process development and bioassay services), focusing on the development of cGMP compliant processes and cell characterization assays for different cell therapy applications. As the global head of process development, Dr. Baghbaderani is currently leading the development activities for viral vector and Cell & Gene Therapy applications across Lonza Cell and Gene Technologies global network.