Key steps to industrialize your process and de-risk your pathway to commercialization in cell and gene therapy

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Key steps to industrialize your process and de-risk your pathway to commercialization in cell and gene therapy

Cell and gene therapies currently face significant manufacturing challenges from quality, quantity, and efficiency perspectives that require specific attention during the early development phase. The use of open, manual unit operations, scalability of existing 2D cell culture systems, access to the analytical methods and implementation of appropriate process analytics in the manufacturing process are examples of these challenges.

These challenges, if not identified and addressed quickly and properly, can negatively impact the transition of the process to manufacturing, leading to recurring failures during manufacturing runs and/or delays to industrializing production of the final product.

This webinar provide a checklist of the challenges and considerations in developing a robust, reproducible, and cGMP (current good manufacturing practice) compliant manufacturing process. Implementation of best practices during the development stage also shared, providing the cornerstones for success for drug developers in cell and gene therapy (CGT). Finally, the value of a phase appropriate process development (PD) and bioassay services (BAS) approach for clinical and commercial applications underlined.

Key learning points include:

Identifying the main manufacturing challenges in the field of cell and gene therapy from the CDMO perspective
Scalability, productivity, cell culture format (2D versus 3D), automation, and process analytics as key areas for evaluation during the early development phase.
Delivering a risk assessment-based approach towards the development of cell and gene therapy processes
How risk assessment can drive defining the focus of development phase to establish a robust and reproducible manufacturing process that meets the GMP design considerations.
What does phase appropriate process development from clinical to commercial manufacturing looks like?
Examples of allogeneic and autologous cell therapy applications and the key steps needed to address the aforementioned gaps during process optimisation with consideration to the specific phase of application.
What are best practices in the development of cell and gene therapy products?
Highlighting establishment of robust and reproducible cGMP compliant processes through appropriate process characterisation, automation, and use of computer-controlled bioreactors.

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Behnam Baghbaderani

Global Head, Process Development, Emerging Technologies at 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.

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