Process development excellence to de-risk and accelerate commercialization of cell and gene therapies
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Process development excellence to de-risk and accelerate commercialization of cell and gene therapies

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Process development excellence to de-risk and accelerate commercialization of cell and gene therapies

In order to commercialize cell and gene therapies and treat large number of patients, it is important to demonstrate the safety and efficacy of these therapies and establish robust and reliable manufacturing processes. Here, we introduce some of the bioprocessing best practices applied in early development phase to de-risk manufacturing and develop commercially viable cell and gene therapies.

Following a carefully planned manufacturability assessment, appropriate development studies must be designed to implement innovative technologies with appropriate in process control and analytical monitoring methods to ensure robustness and reproducibility of the manufacturing process. It is also important to eliminate open and variable manual unit operations whilst incorporating comprehensive characterization assays in the process to verify long-term stability of the products. The development of automated, scalable, computer-controlled 3D bioreactors with appropriate downstream and cell processing technologies may be critical to minimize GMP manufacturing risks and produce high quality cell therapy products.

Behnam Ahmadian Baghbaderani
Behnam Ahmadian Baghbaderani
Lonza Pharma & Biotech

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 (C&GT) 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 post-doctoral program including a two-year post-doctoral fellowship at the National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS). His post-doctoral 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 C&GT applications across Lonza Cell and Gene Technologies global network.