Cell Line Characterization

Cell Line Characterization
In-Depth Characterization for Regulatory-Compliant Cell Banks
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Cell line characterization is foundational to biologics and advanced therapy development, ensuring that your Master and Working Cell Banks (MCB/WCB) are fully defined, stable and free from adventitious agents. At Minaris Advanced Testing, we provide comprehensive cell line characterization services that comply with global regulatory standards and support Investigational New Drug (IND), Clinical Trial Application (CTA) and Biologics License Application (BLA) submissions.

We serve innovators developing viral vectors, vaccines, monoclonal antibodies and recombinant proteins, offering standalone or integrated characterization services based on product stage and regulatory pathway.

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Complete Cell Line Characterization Panels

Minaris delivers full GMP-compliant cell bank testing programs aligned with ICH, FDA, EMA and PMDA guidance.

Our services include:

Sterility Testing

per USP <71> and Ph. Eur. 2.6.1

Mycoplasma Testing

culture-based and NAT-based detection

Endotoxin Testing

USP <85> using kinetic chromogenic methods

Adventitious Agent Testing (AAT)

in vitro/in vivo viral screening

Retroviral Testing

reverse transcriptase assays and electron microscopy

Identity Testing

STR profiling, karyotyping

Viability and Growth Characteristics

cell morphology, doubling time

We also offer customized test panels based on platform, host cell line and vector system, including HEK293, CHO, PER.C6 and proprietary systems.

Bank Types and Materials We Support

Minaris performs characterization of:

  • Master Cell Banks (MCB)
  • Working Cell Banks (WCB)
  • End-of-Production Cell Banks (EOPCB)
  • Modified Cell Lines (e.g., gene-edited or lentiviral transduced)

Integrated with Your Development and Manufacturing Workflow

Minaris’ cell line characterization services are available as standalone offerings or fully integrated into our CDMO development, manufacturing and testing programs. By embedding characterization into the broader project lifecycle, we ensure:

  • Faster release of cell banks for GMP use
  • Streamlined regulatory documentation
  • Alignment between manufacturing readiness and QC requirements

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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