By Yeukyung Yoon and Jangick Lee, Samsung Biologics
Chemistry, manufacturing, and controls (CMC) services are a fundamental element of the drug development process, ensuring a product is consistently manufactured to meet quality, safety, and efficacy standards. In addition to satisfying regulatory requirements for data surrounding the product and its manufacture, CMC’s inherent process optimization contributes to accelerated timelines, lower overall project costs, and minimized risks.
Tailored CMC services also can lead to shorter global licensing timelines and minimize variability in globally registered product details. Still, drug and biologic developers too often settle for the one-size-fits-all service based on a standard CDMO business model, rather than customizable approaches to serve specific client needs. Utilizing workshops to collect and apply client input toward improving and streamlining our operations, Samsung Biologics developed its Customized CMC Solutions to help clients overcome this common hurdle.
Through these modularized service packages, we ensure maximum flexibility for our partners during early-phase drug development by customizing our CMC service according to clients’ shifting demands. We have implemented three base concepts to provide product-specific solutions for a range of clients—from those targeting accelerated timelines that need only the essential components to file an Investigational New Drug (IND) application, to those seeking a detailed study and/or enhancement of their molecules.