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

Cell and gene therapy applications are rapidly growing, though a wide range of challenges remain in the field, especially from a manufacturing perspective. Highly debated topics include scale-up or scale-out, product quality, manufacturing timelines, robustness of analytical methods, and the characterization of cell and gene therapies products and processes. Process development is the foundation for the successful commercialization of cell and gene therapies. Lonza development services start working with our clients at the earliest stages to understand the clients’ needs, focusing on the application and respective process and analytical development requirements. This fuels the development activities focused on establishing a robust and reliable process that meets the GMP design considerations for that specific application, which can then be transferred into manufacturing.

Please enter your email to access content Read now