Considerations For Upstream Biologic Development

By Dr. Joe S. Orlando, Ph.D.

Laying the Right Foundation in Upstream Development

The path from DNA to clinic to drug-in-vial is long and complex. Upstream development is rich with opportunities to guide a  promising molecule toward success. The choices made during upstream development can strongly influence the success of a biologic candidate. Factors such as host cell line selection, media and process scale-up considerations can influence yield and product quality. Additionally, transitioning from pre-clinical development to commercial scale presents the challenge of minimizing project timelines and cost, while complying with regulatory requirements.

Therefore, working with the right partner that demonstrates expertise in all aspects of upstream development — regulations, technology, support services and equipment — empowers developers to make the best possible choices.