CMC Bioanalytical Development

CMC Bioanalytical Development Services | Bioanalytical Testing Solutions

CMC–or Chemistry, Manufacturing, and Controls–is a crucial part of the drug development and manufacturing process. CMC encompasses analytical methods that ensure the safety, efficacy, and consistent quality of pharmaceutical products. 

Proper CMC processes enable quality control by identifying and quantifying manufactured materials, optimizing manufacturing processes, and conducting stability studies on drug substance, drug product, or other constituents of the formulated therapeutic. Bioanalytical methods are employed to measure drug concentrations, determine pharmacokinetic, physical, and chemical properties, and to establish appropriate dosage regimens. 

BioAgilytix is the leading CRO partner for CMC bioanalytical services, allowing sponsors to meet timeline and budget goals while ensuring regulatory compliance and risk mitigation. 


CMC Bioanalytical strategies and approaches

All steps of the drug development process from discovery to approval require CMC support. Plans for monitoring production and strategies for method validation can be initiated early in a drug program but continue to evolve as therapeutics advance through preclinical and clinical stages. Working with an experienced bioanalytical partner in the CMC field can ensure that these testing strategies are appropriate and compliant with global regulatory agencies.

Designing a bioanalytical strategy for manufacturing support

CMC bioanalytical support for the manufacturing process is staged, with additional testing and increasing rigor required as a drug advances through sequential phases of development. The overall bioanalytical strategy can vary depending on the type of drug and the manufacturing processes used to produce it, as well as key aspects of clinical trial design including size, duration, dose, and availability of existing clinical data. 

Some of the universally required CMC bioanalytical tests include assays to determine identity, quality, purity, potency, and stability of the drug substance or drug product. Many additional CMC bioanalyses, such as impurity profiling and biomarker analyses for assessing safety, can also be part of a comprehensive CMC strategy. 

CMC data is a required component of regulatory submissions for advancing a therapeutic into clinical testing and for final drug approval. Designing a complete and phase-appropriate CMC bioanalytical strategy is therefore a complex, and critical aspect of a successful therapeutic program.   

CMC Bioanalytical services

BioAgilytix offers a comprehensive range of services for CMC development to support the unique strategies required for each of our sponsors. Some of the key bioanalytical testing services we provide include:

  • Potency assays
  • Purity and impurity analysis
  • Stability testing
  • Structural characterization
  • Impurity profiling
  • Assay development and validation
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BioAgilytix CMC experience

With our extensive experience in method development and validation, BioAgilytix provides robust and reliable analytical methods to support the quantification, characterization, and assessment of critical quality attributes of your therapeutics. 

Our advanced analytical product testing capabilities enable comprehensive analysis of drug substances and products, ensuring that purity, potency, stability, and impurity profiles are accurately evaluated. 

Frequently asked questions about CMC Bioanalytical testing

BioAgilytix can support a wide range of drug products in CMC development, including biologics, small molecules, combination products, biosimilars, drug-device combinations, and advanced therapies like cell and gene therapies.

In drug development, CMC stands for Chemistry, Manufacturing, and Controls. CMC encompasses the activities and processes related to the chemical composition, manufacturing methods, and quality controls of a drug product. It focuses on ensuring the consistency, quality, and safety of the drug throughout the development and manufacturing lifecycle. CMC considerations are crucial for regulatory submissions and obtaining approval from regulatory authorities.

CMC control strategies in biopharma involve establishing critical quality attributes, developing robust analytical methods, optimizing manufacturing processes, implementing process and supply chain controls, conducting risk assessment and change control, and ensuring regulatory compliance for consistent and safe biopharmaceutical production.