A Two-Part Strategy To Streamline The Path To FIH

By Leslie Wolfe, Ph.D., and Shaunak Uplekar, Ph.D., KBI Biopharma

In cell line development (CLD), the application of targeted integration cell line technology contributes significantly to development speed. Automation in upstream processing and analytical testing, alongside innovative process analytical technology tools, also boost process speed and efficiency. Software solutions, meanwhile, have streamlined the handling of large volumes of data while protecting data integrity.

Additionally, leveraging a production platform with proven scalability empowers KBI Biopharma to transition seamlessly from lab-scale to GMP manufacturing. These valuable capabilities are combined within fit-for-purpose facilities, where a diverse collection of equipment and expertise enables the completion of multiple development and characterization projects safely, efficiently, and in parallel.

KBI Biopharma offers vertically integrated solutions spanning from cell line development to GMP manufacturing that are built to focus on efficiency. These tools and methods have been proven effective across a vast array of product types. The recent incorporation of a transposase-based offering to our CLD workflows further enables us to shorten timelines and increase consistency from transfection to IND-enabling tox material generation.