Enabling Cell Line Tech Transfer For mAb Platform Manufacturing

By Steve Loftus, FUJIFILM Diosynth Biotechnologies

Technology transfer involves the movement of bioprocess knowledge, skills, and technology between a sending and receiving site, which may be within the same organization or across different geographies and companies. This process supports pre-clinical, clinical, and commercial efforts by enabling the development and manufacturing of therapies at various stages of the drug lifecycle.

In early development, technology transfer is often used to scale production by transitioning manufacturing processes from research laboratories to facilities equipped with the expertise and infrastructure required for comprehensive CMC (Chemistry, Manufacturing, and Controls) development and manufacturing. Efficient early-phase transitions are crucial for accelerating pivotal trial testing and delivering maximum patient benefit more quickly.

The development of monoclonal antibodies (mAbs) using CHO cell lines has benefited from established platform knowledge, product development history, and cGMP-compliant infrastructure, which support a low-risk and rapid development model. However, despite these advances, custom process optimization is often necessary to address the unique requirements of specific cell lines, molecules, or manufacturing facilities.

Recent advancements in bioprocess technologies and expertise have enabled greater flexibility in the biopharmaceutical industry. Emerging biopharmaceutical companies often rely on the specialized expertise of CDMOs to streamline and scale production while balancing standardization with customization. This balance is essential for bridging the gap between discovery and manufacturing, ensuring efficient development and large-scale production of therapies like mAbs to meet clinical and commercial demands.