High Touch Project Management
Analytical Development Through ModularCMC™
ModularCMC™ streamlines biologics development through structured, configurable work packages that shorten timelines and support informed decision-making at every stage.
CMC Development Services
Analytical Development and Qualification
Accelerating biologics development through integrated molecular characterization and phase-appropriate analytical methods designed to deliver IND/CTD-ready insights with efficiency and precision.
Analytical Development
Wheeler Bio’s analytical approach aims to provide two things: molecular analysis to define and monitor the product profile and development of fit–for–purpose methods to support IND/CTD filing.
Precision Analytics, Fit-for-purpose
Structural and sequence-level characterization provides valuable insights and guides both process and analytical decisions. Phase-appropriate analytical methods are designed to support Drug Substance and Drug Product release in alignment with ICH Q2(R2) and Q14, with qualification/validation in mind.
Wheeler Bio’s toolbox methods are predeveloped to be widely applicable to antibody and antibody-based molecules, such as multispecifics and Fc-fusion proteins. Application of our toolbox methods increases efficiency without sacrificing quality, reducing the effort required to quickly establish fit-for-purpose methods or streamline further development, if needed. Methods for recombinant proteins can be developed to generate truly product-specific assays.
One Stop, Analytics and QC
Analytical development and QC conducted in-house; methods developed, qualified, and transferred seamlesslyCharacterization
Molecular characterization from day one, establishing the product quality attribute framework that governs method developmentMolecule-Specific Approach
Analytical development built around the molecule, from structural characterization to IND/CTA-ready methods
Analytical Development for Biologics
Wheeler Bio’s end-to-end analytical capabilities ensure a thorough understanding of product quality and performance.
High-resolution elucidation of primary sequence, higher-order structure, post-translational modifications, and glycoform profiles to establish the molecular baseline and define product quality attributes
Evaluation and product-specific tuning of established analytical test methods, including purity, charge heterogeneity, and process residuals, to confirm fitness for intended use without unnecessary method development
Design and development of product-specific binding and relative potency assays, including antigen-binding assays by biolayer interferometry (BLI), to support release and stability testing
Qualification of release and stability methods in accordance with ICH Q2(R2), documenting evidence fit for the intended purpose
Evaluation and implementation of applicable USP compendial methods, including endotoxin, microbial enumeration, pH, osmolality, and visible particulates, to support Drug Substance and Drug Product release
Execution of phase-appropriate stability studies aligned to ICH Q1A(R3) and Q5C guidelines. Long-term, accelerated, and stress conditions provide necessary data to establish preliminary shelf life, storage conditions, and inform formulation development.
Preparation, characterization, and ongoing stability monitoring of Drug Substance Reference Standards to support QC release testing, method qualification, and long-term analytical program continuity
Assessment of Drug Product stability under simulated clinical administration conditions, including dilution in infusion vehicles, container compatibility, and hold time at in-use temperatures
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A Partnership for Biologics Manufacturing Success
Ready to scale-up your antibody-based therapeutic? Contact us to learn how ModularCMC™ derisks the path to the clinic.