Understanding the process of drug development CMC

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and all associated activities, are referred to as chemistry, manufacturing, and controls (CMC).

CMC is conducted throughout drug development to create a product that meets patient needs while demonstrating to regulatory authorities that it is safe for market use and that rigorous testing has been performed. This article explores how CMC drug development works and the reasons its processes are typically outsourced to companies with specific expertise.

Understanding the process of drug development CMC

Image Credit: DSI, a PLG Company

What is drug development CMC?

CMC is a critical element of drug development. It encompasses the evaluation of the physical and chemical properties of an active compound, as well as the finished drug product. In the initial phases, product safety and manufacturability are the focus.

Later, the focus shifts toward controlling the manufacturing process to ensure product efficacy, consistency, and quality. The consistency of the manufacturing process must be showcased to prove that the drug utilized in clinical trials is the same product that reaches the market if approved.

How does CMC drug development work?

Several elements of CMC must be considered when developing a drug product. These include selecting an active form, process development, formulation, quality and compliance, clinical trials, supply chain and manufacturing strategy, and development of the drug product itself. All aspects contain different processes, including developing analytical methods, making prototype formulations, testing and optimization, evaluating the best manufacturing process, report documentation, packaging and distribution logistics, risk assessments, manufacturing processes and scale-up, cleaning validation, and more.

When a company decides to outsource its CMC work, it must have an outsourcing strategy. The CMC experts offer support to the company through a wide array of stages, including:

  • Assessing how a product/development strategy can fail and implementing solutions
  • Analyzing process flows and suggesting improvements
  • Assessing vendors and offering guidance based on firsthand experience
  • Resolving formulation and manufacturing challenges
  • Estimating budgets and timelines
  • Planning toxicology studies
  • Designing preclinical studies for proof-of-concept
  • Product and process characterization
  • Writing and reviewing manufacturing processes

Outsourcing CMC

CMC can be a complicated part of the drug development process, and numerous companies have chosen to outsource these services. Outsourcing CMC offers many benefits, including access to expertise and technology not available in-house, improvements in time-to-market, and the requirement to prioritize certain stages of development.

Some primary services include the creation of a regulatory framework, preparing, writing, and submitting CMC documentation, and analytical services to confirm that the starting materials and drug products are controlled. These crucial stages will play a large role in whether a drug product meets regulatory requirements and receives market approval.

DS InPharmatics: Drug development CMC

DS InPharmatics has a team of CMC experts who provide various consulting services. Through its CMC services, DS InPharmatics supports compliance and devises appropriate strategies for biologics and pharmaceuticals. Employing DS InPharmatics early in the CMC drug development process will save companies significant time and money.

The CMC consulting services DS Inpharmatics provides include the following:

  • Analytical Services
  • CMC Regulatory Affairs Support
  • Drug Substance Services
  • Drug Product Services
  • Materials Characterization and Formulation Development
  • Process Development, Optimization, and Validation
  • Supply Chain Services
  • Stability Program Management and Design
  • Vendor and Contractor Identification and Management

About DS InPharmatics LLC

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: Feb 12, 2024 at 9:25 AM

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