GMP-compliant testing for master and working cell banks, including sterility, mycoplasma, adventitious agents and species identity.
Explore Cell Line Characterization
A potency assay for a monoclonal antibody should quantitatively measure the antibody’s biological activity, which reflects its mechanism of action and most accurately mimics the expected function in the patient receiving it.
See Analytical Development
Expert and proven approach to in-transfer and verification of client assays, including gap assessments, optimization, bridging and full qualification or validation.
See Assay Transfer
Innovative and regulatory-compliant study design with orthogonal approaches, high-titer virus stocks and optimized spiking strategies to maximize log reduction values (LRV) for global regulatory submissions.
See Viral Clearance Studies
Validated potency, purity and safety assays tailored to mAbs, ensuring timely and compliant clinical and commercial release.
Explore Lot Release Testing
ICH-compliant stability studies to establish shelf life, support comparability and de-risk formulation or process changes.
Learn About Stability Studies
Minaris Advanced Testing provides GMP-compliant testing services for monoclonal antibodies (mAbs) and recombinant proteins.
With over 40 years of biosafety and analytical expertise, our routine and custom testing services help you achieve regulatory compliance at every phase, from early development to commercial supply.
Testing workflows at Minaris Advanced Testing are designed to shorten timelines while maintaining audit-ready documentation. Our team of seasoned experts will provide efficient data packages to support FDA and EMA submissions. From research cell banks through lifecycle management of commercial programs, our services deliver the scientific rigor and regulatory alignment needed to accelerate therapies to market.
Knowledge Center
Through our Knowledge Center, we share data-driven insights and best practices from across the industry to help you stay ahead of evolving expectations.
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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.
