How Drug Development CMC Works 

How Drug Development CMC Works 

When pharmaceutical companies develop a new drug product for the market, there are many different steps a potential product must go through to determine and control its safety, manufacturability, effectiveness and reliability. These processes, and all activities within, are known as chemistry, manufacturing, and controls (CMC).

CMC is done during drug development to develop a product that addresses the needs of the patient while demonstrating to regulatory authorities that the drug product is safe for market use and that thorough testing has been completed. Continue reading to examine how CMC drug development works and why its processes are often outsourced to companies with specific expertise.

What is Drug Development CMC?  

CMC is a crucial part of drug development. It involves assessing the chemical and physical properties of an active compound and finished drug product. In the early phases the focus is on product safety, and manufacturability. In later phases the focus is on how the manufacturing process must be controlled to ensure product efficacy, quality and consistency. The consistency of the manufacturing process must be demonstrated to show that the drug used in clinical trials is the same product that reaches the market if approved.  

How Does CMC Drug Development Work?  

There are many aspects of CMC that need to be considered for developing a drug product and its life cycle. These include selecting an active form, formulation, process development, clinical trials, quality and compliance, supply chain and manufacturing strategy and drug product development itself. Each aspect contains different processes, such as developing analytical methods, making prototype formulations, evaluating the best manufacturing process, optimization, and testing, report documentation, packaging and distribution logistics, manufacturing processes and scale-up, risk assessments, cleaning validation, and more. 

Once a company has decided to outsource its CMC work, they need to have an outsourcing strategy. Moving forward, the CMC experts can support the company through a wide range of stages, including: 

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

Outsourcing CMC  

Chemistry, manufacturing, and controls can be a complex part of drug development, and many companies choose to outsource these services. Outsourcing CMC provides numerous benefits, with access to expertise and technology that is unavailable in-house, improvements in time-to-market, and the need to prioritize certain stages of the development process.  

Some primary services offered include the development of a regulatory framework, writing, preparing, and submitting CMC documentation, and analytical services to ensure starting materials and drug products are controlled. These stages are all critical and will play a big part in whether a drug product meets regulatory requirements and later receives market approval. 

DS InPharmatics: Drug Development CMC 

DS InPharmatics has a team of chemistry, manufacturing, and controls experts who offer a range of consulting services. Through our CMC services, we can support compliance and devise suitable strategies for biologics and pharmaceuticals. By employing us early in your CMC drug development process we can save your company significant amounts of money and time.  

The CMC consulting services DS Inpharmatics provides include the following: 

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

Contact us today for more information on working with a CMC support and consulting business to support your drug discovery processes.