The healthcare industry’s demand for safe, effective, and accessible advanced therapeutics is rising rapidly. Drug developers are becoming more competitive in the race to develop and expand their drug pipelines, especially for complex molecules, to meet this demand and remain viable in this fast-evolving industry.
As a result of the competition toward biologics innovation, drug developers expect contract development and manufacturing organisations (CDMOs) to provide tailored services, especially in the field of chemistry, manufacturing, and controls (CMC).
As a strategy for maintaining consistent quality from drug development to commercialisation, CMC nowadays has to be specifically designed to accommodate the unique characteristics of complex molecules, like bispecific antibodies (bsAb) and antibody-drug conjugates. CDMOs can provide customised CMC guidance by enhancing their service flexibility and client-centric communication.
Building a Framework to Design a Customised CMC Strategy
CMC is a fundamental framework that dictates early drug discovery to final delivery to patients, meaning it must be designed and executed with pre-emptive plans to respond promptly to challenges that may arise. Drug developers that want to achieve clinical milestones in time should embrace CMC as the guiding principle of drug development success.
Consistent product quality is a critical criterion that the U.S. Food and Drug Administration (FDA) evaluates during its review of clinical applications. The FDA’s approval threshold becomes more stringent should molecules concern multi-targeting antibodies or conjugation. By maintaining consistent quality, a nascent molecule derived from a biological organism stays pure, potent, and stable until it enters the human body and generates the desired therapeutic effect.
Building a robust CMC framework requires heterogeneous elements to work in harmony: comprehensive knowledge of candidate molecules, innovative technologies, advanced platforms, and experienced people who know how to execute each project stage right the first time. According to an industry report, at least 1,500 biologics are in trials.1 Whether a monoclonal antibody, bsAb, or Fc-fusion protein, each molecule’s distinctive characteristics require a custom CMC approach to maintain its efficacy until it is aseptically filled into a vial. Developing a tailored CMC strategy, however, is resource-intensive work, which can impact drug developers with limited capital. Therefore, drug developers partner with CDMOs, expecting to be provided with customised CMC plans for their pipelines. To ensure client satisfaction, CDMOs must develop a standardised, flexible CMC strategy that is tailored to a molecule’s characteristics or client-specific requirements.
