Analytical Services 

In the manufacture of cell therapy products, the independent quality control system is a key element that ensures the required level of quality and safety of the finished cell and gene therapy. Minaris Regenerative Medicine has experience in developing a comprehensive control strategy outlined in product specific sampling plans to confirm the identity, purity, potency, and safety of your cell product.


Quality Control and Analytical Services for Cell and Gene Therapies

The control strategy for cell and gene therapies also includes test methods for in-process controls and release samples with acceptance criteria and final product specifications, as well as release criteria for starting and raw materials and intermediates. We apply phase-appropriate ICH Q2-based validation strategies and perform required stability studies. Our dedicated teams offer guideline-compliant transfer strategies for analytical methods as well as in-house development and validation activities. 

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Analytical methods for cell therapy products

Minaris Regenerative Medicine has a broad portfolio of analytical methods that are performed either by our specialists or by qualified accredited laboratories. Our laboratories are suitable for BSL-1 and BSL-2 analytics with fully GMP-qualified and monitored equipment. In addition, we offer back-up solutions for the most important device platforms, e.g., flow cytometers, cell counters and qPCR devices.

We offer a comprehensive analytical assay portfolio for in-process controls and release testing to demonstrate
  • Identity
  • Purity
  • Impurity
  • Potency
  • Safety

Analytical Assay Portfolio

  • Cell count and viability assays (automated, manual)
  • Expression of surface and intracellular markers with Flow Cytometry (FC)
  • Cell-based potency assays e.g., Treg suppression assay, cytotoxicity assays, functional protein expression assays
  • Cytokine release assays by ELISA (quantitative and qualitative) or Flow Cytometry
  • Colony-Forming Unit (CFU) assays (automated)
  • Transduction efficiency by Flow Cytometry or single cell ddPCR
  • Vector copy number (VCN) by qPCR or ddPCR
  • Promotor activity (mRNA expression)
  • Genomic analyses (qPCR, ddPCR, Next Generation Sequencing on/off-target, genomic stability, Karyotyping) in-house/at accredited external labs
  • Microbiological safety testing (sterility, endotoxin, mycoplasma, Rapid Microbial Methods, adventitious virus testing) of drug products in-house/at accredited external labs.
    • In-house sterility testing (Rapid via BacT or direct inoculation per USP)
  • Residual virus testing

Services may differ in different Minaris regions.

Analytical method Validation

  • Phase-appropriate validation approach for in-process and release testing
  • Validation studies: testing of selected parameters such as specificity, accuracy, robustness to demonstrate the assay’s suitability for the intended purpose.
  • Full validation of analytical procedures according to ICH Q2 guidelines
  • Verification of compendial methods


Stability testing of drug products according to ICH Q1 guidelines:

  • Long-term stability study
  • Real-time stability study
  • Ongoing stability study
  • Accelerated stability study
  • Stress testing

Material Qualification and Release of cell therapy products

  • Risk-based approach to qualify material for use in clinical and commercial production
  • Incoming goods control and testing for raw materials
  • Material selection support during development and product life cycle

Microbiology Testing for cell therapy products

  • Continuous trending using an electronic environmental monitoring system
  • Customer specific EM reports
  • Germ ID up to species level and antibiotic resistance testing