Deep expertise in biologics CMC testing from preclinical to commercial

Manufacturing biologics is a sophisticated process with inherent product variation that can affect efficacy, stability, and immunogenicity. Solvias helps you navigate these challenges with a comprehensive array of innovative biologics testing solutions. Our biologics expertise helps ensure the quality, safety, and effectiveness of your product.

Broad-ranging capabilities

Solvias provides a comprehensive suite of cGMP-compliant biologics CMC testing services. Our unique blend of biological and physical-chemical testing paired with specialized services enables us to apply our deep expertise to the fastest-growing areas of biologics development.

Characterization and comparability

Expert characterization team proficient in primary and higher-order structures, PTM, charge variant identification, potency assays.

Method development & validation

Broad tool kit of customizable, in-house developed analytical platform methods with an orthogonal approach for flexibility and risk reduction.

Drug substance & drug product release testing

Analytical testing for drug substances and products with a robust quality system ensuring late-stage and commercial release compliance.

Stability studies

Comprehensive stability testing portfolio with ready capacity and E&L capabilities covering all major dosage forms and complex delivery systems.

Covering a variety of modalities

Solvias scientists have experience providing analytical services for a range of therapeutic modalities, including:

  • Monoclonal antibodies (mAbs)
  • Antibody-drug conjugates
  • Bispecifics
  • Recombinant proteins and glycoproteins
  • Protein conjugates (PEG)
  • Peptides

Expertise at your service

Our CMC testing offerings are rooted in a deep understanding of the critical quality attributes that impact biologics development, ensuring reliable, cost-effective solutions. You enjoy direct access to our subject matter experts and project managers. By keeping technology and testing capabilities in-house, we’re able to provide accurate results rapidly, helping avoid costly program delays.


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Contact us for a complimentary consultation