Therapy developers face significant testing challenges: long method development cycles, poor reproducibility in complex assays, region-specific regulatory requirements and high per-sample costs.
Fragmented data systems can introduce additional delays, making it challenging to maintain audit readiness. Minaris Advanced Testing addresses these barriers with integrated testing technologies that ensure accuracy, speed and compliance for biologics and advanced therapies.
Shortening assay development timelines with automated platforms and expertise
Improving reproducibility in cell-based potency and molecular assays
Reducing cost and complexity with integrated, high-throughput systems
Ensuring audit-ready compliance through electronic lab systems and global quality alignment
Reducing timelines for custom assay design and validation.
Novel assays for potency, identity and purity often require 4–6 months to develop, which can delay IND or IMPD filings. Minaris’ analytical development teams apply platform-based methods and advanced instrumentation to shorten these timelines. Capabilities include custom flow cytometry panels, qPCR for residual DNA and vector copy number and ELISA-based potency assays. High-throughput instruments and validated workflows enable faster qualification and transfer across global sites.
Minaris Advanced Testing applies innovative technologies that reduce risk and accelerate timelines. Our advanced laboratories span molecular, microbiology, virology and quality control platforms, supported by a system that ensures audit-ready compliance. With hundreds of pre-clinical programs and 25+ commercial lot release programs delivered, Minaris provides therapy developers with the scale and reliability needed to bring products to patients faster.
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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.
