Cell-Based Potency Assay GMP Analytical Platforms

Unlock Advanced Cell-Based Potency Assays with Cutting-Edge GMP Analytical Platforms

PCR/ddPCR: Advanced Gene Analysis for Precision Potency Testing

Pharmaron advances scientific excellence with our PCR-based analytical assays. Explore a comprehensive range of PCR platforms—qPCR, ddPCR, and dPCR—to drive cell and gene therapy product innovation. PCR is a critical tool in evaluating the potency and quality of these therapies. Discover how Pharmaron’s advanced PCR methods can optimize potency assays and ensure the highest standards for CGT drug products.

  • MOA-Dependent Gene Expression Detection: Utilize real-time PCR and digital PCR to detect gene expression in cell and gene therapy products based on their Mechanism of Action (MOA). PCR can quantify expression levels by designing specific primers, providing crucial insights into therapeutic potency.
  • Vector Integration and Transgene Copy Number Analysis: Ensure the efficacy and stability of cell therapies like CAR-T with PCR-based methods. Quantitative PCR (qPCR) and digital PCR (ddPCR/dPCR) help detect vector integration and quantify transgene copies in T-cell genomes.
  • Infectious Titer Quantification: Beyond traditional TCID50 assays, PCR platforms offer more sensitive and reliable quantification of viral titers, essential for evaluating gene and cell therapy safety and effectiveness.
  • Contaminant Detection: Employ PCR to detect residual viral or bacterial DNA contaminants, enhancing the safety and purity of therapeutic products.
  • Vector Titer Evaluation: Use qPCR or ddPCR/dPCR to accurately measure viral vector titers in gene therapies, which is crucial for proper dosing and therapeutic efficacy.
  • Quality Control and Batch Release: Integrate PCR assays in quality control testing to assess gene expression, vector integrity, and contaminant absence, ensuring the safety, consistency, and potency of products.
Precision and Innovation in Cell-Based Potency Assays

Flow Cytometry: Precision and Innovation in Cell and Gene-Based Potency Assays

Pharmaron’s GMP-compliant Flow Cytometry techniques deliver advanced methodologies designed for precision and reliability, offering unparalleled insights into potency assessments for cell-based therapies.

Assay Applications:

  • Assess transgene protein expression, receptor occupancy, cytotoxicity, activation, antibody binding, and more.
  • Analyze purity and classify analytes using state-of-the-art flow cytometry technology.

Flow Cytometry Expertise:

  • Development, qualification, and validation of GMP lot-release assays for biologics and CGT.
  • Experience with diverse Mechanisms of Action (MOAs).
A scientist in a lab coat operates an LC-MS/MS system, adjusting components while wearing blue gloves for precision in potency analysis.

LC-MS/MS: High-Precision Potency Determination

Pharmaron’s advanced LC-MS/MS technology provides accurate potency determination. Our GMP-compliant platform offers precise quantification of a wide range of analytes, reinforcing the reliability of your potency assessments.

Applications:

  • Identification and quantification of small molecules, biomarkers, oligonucleotides, peptides, proteins, amino acids, fatty acids, lipids, and ADCs.
  • High-resolution detection enables comprehensive characterization and quantification of complex biologics.

Capabilities:

  • Seamless interfacing with ultra-high performance chromatographic systems.
  • Supports a variety of chromatographic techniques (Reverse Phase, Normal Phase, HILIC, Chiral, SEC, SFC).
  • High sensitivity and specificity through a wide linear range.
A scientist operates the Maestro Z system, using a multi-well plate for noninvasive electrical measurements of cultured cells in a lab setting.

LBA: Versatile Immunoassay Solutions for Potency Testing

Pharmaron’s specialized ELISA and ligand-binding assay (LBA) methodologies are tailored for potency assessments. Our GMP-compliant platforms integrate cutting-edge enzymatic and cell biology methods to deliver robust and reliable results.

  • Immunoassay Capabilities:
    • Comprehensive suite of assays: ELISA, AlphaLISA, MSD, ELLA, Western blot, in-cell Western blot, Luminex, enzyme activity assays, fluorescent and luminescent assays.
    • Cell-based platforms such as ELISpot/FluoroSpot and Flow Cytometry are fully validated and GMP-compliant.
  • Guidance and Support: Unsure which platform suits your needs? Our team of experts can guide you in selecting the best platform tailored to your specific requirements.
  • Alternative Platforms for Potency Assays
  • Axion Biosystems – Maestro Z: Real-time, continuous label-free monitoring with impedance-based cell analysis for diverse MOAs, including ion channel activity, cell kill assays, and optogenetics.
  • Thermo Fisher CellInsight CX5 HCS: High-throughput imaging for functional and activity assays such as protein-protein interactions and subcellular localization.

Resources and Technical Support

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Potency Assay Development for Cell and Gene Therapy Whitepaper

Poster titled "Development of in vitro potency assays to evaluate early activation, Granzyme B secretion, and cytotoxicity of CAR-T cells," featuring detailed charts and graphs. The background includes purple and blue geometric patterns with the Pharmaron logo in the bottom right corner, underlining their expertise in bioanalytical development. A download button is provided below.

Development of in vitro Potency Assays to Evaluate Early Activation Poster

Promotional image for Pharmaron's "Potency Assay Guide" ebook. Left section shows the ebook cover, with icons for safety, integrity, and results. Right section has "Potency Assay" text with a "Download eBook Below" button, overlaid on a DNA strand background that hints at bioanalytical development.

View our Potency Assay for Cell and Gene Therapy Products eBook

A promotional poster displays scientific information on leveraging imaging technologies for drug potency testing in orthotopic and heterotopic tumor models. It includes text, graphs, and images related to Preclinical ADME studies. A "Download Below" button is visible, along with Pharmaron's logo.

Leveraging the IVIS imaging technologies for drug potency testing Poster