Developing Cell and Gene Therapies with a CDMO
Developing cell and gene therapies (CGTs) is a complex and highly specialized process that often requires collaboration with various experts and organizations. One crucial partner in the drug development process is a Contract Development and Manufacturing Organization (CDMO). Review the following steps outlining how to efficiently collaborate with a CDMO partner.
Collaborate with the CDMO to optimize and develop the manufacturing process for your cell or gene therapy. This involves defining cell lines, vectors, and other critical process parameters (CPPs). The goal is to establish a robust and scalable process that meets regulatory requirements while maintaining product quality and consistency.
If your process is already developed, the CDMO will work with your team to transfer the technology from your lab to their facility. This involves providing detailed documentation, protocols, and training to ensure a smooth transition. Should the process be developed or optimized at the CDMO, there is a similar technology transfer to GMP manufacturing.
Manufacturing and quality control
The CDMO will scale up the manufacturing process to produce clinical trial material or commercial products. Rigorous quality control testing is conducted at various stages to ensure the product’s safety, efficacy, and consistency. The CDMO will adhere to Good Manufacturing Practices (GMP) regulations to meet quality standards.
CDMOs experienced in cell and gene therapies are well-versed in regulatory requirements. They can assist in compiling the necessary documentation for regulatory submissions, such as Investigational New Drug (IND) applications and Biologics License Applications (BLA), Chemistry, Manufacturing, and Controls (CMC) sections, and interactions with regulatory agencies.
Clinical trials and commercialization
The CDMO can produce material for clinical trials and, if successful, assist in the transition to commercial manufacturing. They will continuously monitor and optimize the manufacturing process to ensure consistent product quality and meet increasing demand.
Maintain open communication and collaboration with the CDMO throughout the development and manufacturing process. Regular meetings and updates will help address any challenges, modifications, or improvements that may arise.
About The Center for Breakthrough Medicines (CBM)
Center for Breakthrough Medicines (CBM) is a purpose-built and patient-driven, cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, end-to-end, best-in-class services from pre-clinical through commercial, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.