New Whitepaper: 2021 Trends Driving CMC Information from Clinical Trials to Commercialization

Chemistry, manufacturing, and control (CMC) information about an investigational new drug is a vital part of every clinical trial application. CMC is used to ensure the safety, identity, quality, purity, strength, and potency of the investigational drug. CMC information must also be updated as a drug proceeds through clinical trials. Following successful clinical trials, the application for drug licensure must also contain CMC information for production at-scale.

CMC Regulations and Challenges

CMC information required for a clinical trial application covers the drug substance, the drug product to be administered during the clinical trial, the manufacturing process, placebos to be used, labelling, and quality control measures.

A few examples of CMC are:

• Physical, chemical, and biological characteristics
• All components used in manufacturing and present in the drug product
• Stability data for the drug substance and product
• Quality control measures during manufacturing and clinical trials

Drug substance data contained in country-specific pharmacopoeias can assist in the design of drug production processes and preparation of CMC information.

Gene therapy research has also experienced rapid growth in the last five years. A few of the novel CMC considerations for such therapies are development of appropriate testing protocols for cells and vectors, potency assays, and biological reference standards.

Current and Emerging Trends

One of the strongest trends today is the increasing use of Contract Manufacturing Organizations (CMO) and Contract Development and Manufacturing Organizations (CDMO) for different steps in the drug development and approval process. A CMO can prepare the regulatory paperwork for clinical trial applications and may also design the drug manufacturing process and conduct the manufacturing. A CDMO also offers drug development services such as cellular and in vivo modelling and other preclinical activities. CMO/CDMO benefit drug companies by providing task-specific expertise, helping control capital investment costs, and speeding up clinical trial and commercialization approval.

Another emerging trend is the conversion of drug production from batch manufacturing to continuous process manufacturing. A primary driver of this trend is the increased efficiency that can be realized by having all parts of the production process in one location. Such a conversion will require the development of innovative and robust quality control measures.

The increased use of digital technology, advanced analytical techniques, and advanced data analytics is another emerging trend in drug discovery and development. Implementation of these technologies will enable advances such as in silico prototyping, predictive modelling, and real-time continuous monitoring of the manufacturing process.

Summary

CMC information is a crucial part of gaining approval for clinical trials and commercialization. It is also an important consideration in the development of new types of drug therapies and the use of innovative analytical and production technologies.

To dive deeper into CMC compliance, challenges, and trends, please read our whitepaper.