What Should Companies Look For When Selecting a CDMO For Process Development (PD)
The best PD offerings are integrated services over the entire therapeutic development cycle–from initial development to commercialization. They can meet aggressive and ambitious timelines, as well as produce and scale up complex products with greater efficiency.
When searching for a Contract Development Manufacturing Organization (CDMO) with optimized process development practices, it’s most important to look for process development knowledge.
The best CDMOs emphasize innovation, cost-effective operational scales, and customized platforms for each client’s unique project needs. Their processes are highly efficient and supported by expert teams comprised of industry leaders with years of knowledge and incomparable experience. Analytical is required for making sure the therapy is: Identified (as expected), Safe, Potent, Pure, and Stable. FDA clinical holds have often been due to safety issues and lack of potency assays
Processes should be designed with scale-up in mind to support the movement to commercial product volumes and reduce manufacturing issues. This allows for higher product quality, lower processing costs, and faster time to market. To create these processes, your CDMO partner should utilize advanced process development and scale-up technologies to optimize efficiency and cost savings.
They should also prioritize improving development from expression to release and validation. It is essential to cover all upstream and downstream unit operations. Through process optimization, the focus should be placed on cell line development/banking, scale-down, process characterization, viral clearance studies, tech transfer, GMP manufacture, and validation.
When evaluating CDMO process development programs, prioritize their emphasis on innovation and continuous improvement. Looking for CDMOs with a flexible and extremely skilled workforce as well as tech transfer and scale-up experience. Also, consider their process design for risk mitigation to achieve the highest quality required by regulatory authorities.
Scale-down and scale-up models must be in place, with the knowledge and experience of an expert team to determine the best processes for implementation. Being able to predict large-volume process behavior allows for the growth of production and development. You should also look for the rapid development of scalable processes. Scaling should look beyond reducing material waste, to speed up process development.
Your CDMO’s process development procedure must emphasize high throughput advances. It’s a great benefit if they incorporate state-of-the-art process development labs into their program building.
Learn more about Center for Breakthrough Medicines process development capabilities: https://breakthroughmedicines.com/process-development/