High Touch Project Management
Formulation 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
Formulation Development
A stage‑appropriate formulation development approach customized to the molecule’s target product profile
Biologics Formulation
A multi-staged formulation development approach designed around your molecule’s stability profile and lifecycle stage, from platform screening for standard programs to fully bespoke development for complex or novel protein formats.
Molecule-Led Formulation
mAb programs are screened against commercially proven buffers and excipients, which are selected and optimized using accelerated stability data to efficiently confirm a lead formulation.
Deeper analysis of aggregation and conformational stability is applied where complex formats require it, including multispecific and Fc fusion programs.
For recombinant proteins with distinct physicochemical or stability profiles, formulation development begins with characterization of the molecule’s relevant stability properties.
Integrated Development
From first characterization to final formulation, a single integrated development threadMolecule-Led
Formulation science that starts with the moleculePrioritized Stability
Stability risks define the formulation development strategy
Data-Driven Formulation
A data-driven formulation approach that takes into account molecular characterization and prioritizes long-term stability
Evaluation of the molecule’s physicochemical properties, including aggregation propensity, colloidal and conformational stability, and chemical degradation pathways to establish a stability risk profile that informs formulation strategy and candidate selection
Systematic evaluation of established excipient systems and buffer conditions against a defined analytical panel, designed to identify a lead formulation candidate efficiently for programs where platform conditions are appropriate
Design-of-experiment (DoE)-based screening of buffer composition, pH, excipient type and concentration, and surfactants
Evaluation of formulation candidates under accelerated and stress conditions, thermal, freeze-thaw, mechanical, and oxidative stresses, to differentiate stability profiles and support lead formulation selection
A statistical modeling approach applied to DoE stability data to identify optimal formulation conditions and understand the relationship between excipient variables and stability outcomes, reducing the experimental burden of formulation design space navigation without sacrificing analytical rigor
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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.