Analytical method development carried out by a team well-versed in regulatory filings.
The Right Test at the Right Time
Our biologics analytical services cover all stages of product and process development: from early stages of clinical development to commercialization. Thanks to our extensive experience developing advanced analytical methods, we are able to work with a diverse range of biologic modalities. Count on our experts to guide you through your product’s journey as we work with you to determine the right tests for each phase of your product development, smoothing your path to regulatory approval and shortening timelines to clinic or market.
Our team possesses formidable analytical development expertise, and are adept at crafting and implementing cutting-edge methods for thorough characterization and quality assessment. With a commitment to precision and innovation, Tanvex empowers clients with insightful analytical solutions that ensure the integrity and efficacy of their therapeutic offerings.
- Our Experience, Amplified: Highly experienced scientists, with over 20 years’ experience in advanced method development
- Scientific Artistry: A creative scientific approach to developing the methods that will best determine your product’s characteristics and efficacy
- Comprehensive Offering: Fluent with all standard test methods, including cell-based potency and other MOA bioassays
- Integrated Analytics: Fully integrated analytics and testing ensures that manufacturing customers don’t need to coordinate multiple vendors prior to lot release, accelerating the path to clinic
Tanvex stands as a leader in analytical development, proficient in devising and deploying state-of-the-art methodologies to comprehensively analyze and ensure the quality of your novel biologics. With a dedication to accuracy and advancement, Tanvex offers tailored analytical solutions that provide clients with in-depth insights into the performance and integrity of their biologics and biosimilars.
- Primary sequence analysis: intact mass, peptide mapping, sequence variant analysis by LC-MS
- Higher order structure: disulfide, free thiols
- Glycan and Post translational modification analysis by LC-MS
- Product related impurities: SEC, CEX, RP, HILIC, HIC, CE-SDS, cIEF
- Process related impurities: HCP, hcDNA, Protein A, PEG, and various impurity assays for microbial systems
- Cell based potency assays for MOA: proliferation, inhibition of proliferation, ADCC, Delfia, ready-to-use cells incorporation
- Binding assays for MOA: ELISA, AlphaLISA®, SPR
- Excipients and other miscellaneous: polysorbate, amino acid analysis, titer
- Assay development for in-process controls, lot release and stability
- Development of product release and stability specifications
- Phase appropriate assay qualification / validation per ICH Q2R2
- Assay transfer and support of assay validation per USP <1224>
- Characterization of product and process related impurities for regulatory submissions
- Comprehensive comparative analytical assessment for 351(k) submission
- Establishment of interim reference standard and reference standard characterization
- Development of bioassays for mechanism of action per USP <1032>
- Comparability assessment for process changes