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Deep expertise in biologics testing services for CMC, 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 services for CMC. 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 testing services. Our unique blend of biological and physical-chemical testing paired with specialized CMC 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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