CMC Analytical Development Services for All Phases of Drug Development

CMC (Chemistry, Manufacturing, and Controls) analytical services encompass the specialized laboratory testing, method development, and strategic regulatory documentation required to bring a new drug or biologic from early development through clinical trials and into commercial production. CMC analytical services focus on figuring out what needs to be tested, how to test it, and prove that the manufacturing process consistently yields a high-quality product from batch to batch.   

Pillars of CMC Analytical Services at BioAgilytix:

• Analytical Method Development: creating specific scientific techniques needed to measure critical quality attributes, i.e. cell-based bioassay
• Characterization: physicochemical and structural properties, higher order structure, post-translational modifications
• Impurity Profiling: product and process related impurity testing
• Comparability Testing: confirming safety and efficacy profiles remain unchanged due to manufacturing or process related changes

GMP analytical testing refers to laboratory analysis of pharmaceutical products, biologics, and medical devices executed in compliance with current Good Manufacturing Practice (cGMP) regulations. GMP laboratories are expected to adhere to a rigid quality system, where regulations are enforced by government agencies, such as FDA and EMA.
The quality systems must have mechanisms in place for:

• Equipment Qualifications: installation, operational and performance qualifications, calibration and maintenance plans, and thoroughly documented use history log
• Strict Documentation Practices: for equipment use as well as method execution
• Method Validation: standard chemistry and analytical methods must be validated per ICH Q2(R2), proving they are capable of being accurate, precise, specific, robust, and repeatable for their intended purpose
• Investigational Process: Out of Specification (OOS), Out of Trend (OOT), and Out of Expectations (OOE) investigations need to be part of the quality systems method lifecycle management

Analytical method development focuses on designing and optimizing analytical procedures capable of generating reliable data for a specific application. Method validation demonstrates that a developed method consistently performs according to predefined acceptance criteria and is suitable for its intended use in regulated and cGMP environments.

Product characterization is the foundational scientific process of identifying and understanding the precise physicochemical, biological, and structural properties of a drug molecule. This testing helps sponsors understand all the critical quality attributes of their product. These data are essential for supporting development, manufacturing, and clinical decisions.

Critical quality attributes are physical, chemical, biological, or microbiological properties that help ensure a therapeutic product meets predefined quality, safety, and efficacy expectations. CMC analytical testing strategies are often designed to evaluate and monitor CQAs throughout development and manufacturing.

Stability testing evaluates how a product’s quality changes over time under defined storage conditions. Stability studies help establish shelf life, storage requirements, product specifications, and long-term quality expectations while supporting regulatory submissions and commercialization activities. 

Release testing is performed to evaluate whether a product meets predefined quality specifications before it is released for clinical use or commercial distribution. CMC testing control strategies may include assessments of safety, identity, strength, purity, and product quality as critical quality attributes.

Yes, a single laboratory facility can support both analytical development and GMP testing. Housing both laboratory functions together offers immense lifecycle benefits, primarily driven by efficiency. Analytical method transfers from development to GMP validation are notoriously difficult. When analytical development and GMP testing teams operate within a coordinated scientific organization, sponsors can benefit from improved communication, reduced technology transfer complexity, greater analytical continuity, and a more efficient path from development through commercialization. Our integrated approach is designed to support seamless program progression while leveraging specialized laboratory expertise.

Analytical testing generates the data used to demonstrate product quality, consistency, safety, and performance. These data support regulatory submissions including INDs, BLAs, MAAs, and other filings by helping sponsors establish appropriate analytical control strategies and product specifications. 

Analytical requirements vary by product and modality but often include method validation, product characterization, release testing, stability studies, comparability assessments, and critical quality attribute evaluation. These activities help ensure products meet regulatory expectations and manufacturing quality requirements. 

Different therapeutic modalities often require unique analytical approaches. Gene therapies, cell therapies, ADCs, proteins, peptides, vaccines, and RNA therapeutics each present distinct analytical challenges that may influence method development, characterization strategies, quality assessments, and GMP testing requirements. 

As programs advance from development through commercialization, maintaining scientific continuity can help reduce variability, improve knowledge transfer, support analytical consistency, and streamline regulatory and manufacturing activities. A connected analytical strategy helps ensure product quality remains a central focus throughout development. 

Comparability testing helps sponsors evaluate whether product quality attributes remain consistent following manufacturing, process, formulation, or analytical changes. Comparability testing strategies support product characterization, regulatory submissions, manufacturing consistency, and long-term product quality objectives.