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.

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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

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

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