Assay Transfer

Assay Transfer
Robust, Risk-Minimized Assay Transfers to GMP Testing Environments

Transferring analytical methods from development to a GMP setting is a critical milestone and a potential risk point if not managed with scientific rigor and operational discipline.

At Minaris Advanced Testing, our Assay Transfer services ensure that methods, whether developed internally by clients or externally by vendors, are transferred with precision, compliance and performance integrity. We partner with biopharma companies, academic innovators and CDMOs to bring existing assays into our testing platform and ready them for use in lot release, stability and in-process control. Our approach includes comprehensive gap assessments, bridging studies and qualification/validation protocols, tailored to the phase and intended use of the method.

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Full-Service Assay Transfer Approach

Minaris delivers a structured, data-driven transfer process designed to de-risk assay onboarding and enable rapid deployment in our GMP labs.

Our services include:

Initial method feasibility assessment and protocol review

Risk-based gap analysis to identify performance, material, or equipment differences

Bridging study design and execution using reference standards or actual samples

Training and tech transfer documentation for client-originated methods

Method optimization and remediation , if required

Qualification or validation per ICH Q2(R2) and relevant guidelines

We also support parallel assay development or optimization in cases where the incoming method does not meet the required robustness or regulatory standards.

Assay Types We Commonly Transfer

Minaris has successfully transferred and qualified methods across a wide range of assay types and modalities:

  • Potency assays – cell-based with endpoints ranging from qPCR and ELISA to flow cytometry and HPLC
  • Identity and purity assays – FACS, Western blot, SDS-PAGE
  • Platform-specific methods – for viral vectors, gene-modified cells, monoclonal antibodies and recombinant proteins

Embedded in a Global GMP Testing Ecosystem

Assay transfer at Minaris is executed by scientists who are co-located with our GMP QC labs. This vertical integration ensures:

  • Faster resolution of technical issues
  • Real-world performance data from clinical or commercial lots
  • Streamlined transition to release, stability and in-process testing
  • Global harmonization for multi-region programs
We offer these services independently or as part of an integrated CDMO program and support global submissions with full documentation and regulatory alignment.

Ready to Get Started?

Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.

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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.

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