Cell and Gene Therapy Services

Optimized Methods for Cell and Gene Therapy Products

Cell and Gene Therapy Services

Cell and Gene Therapy Services

Frontage’s CMC Cell and Gene Therapy (CGT) division is staffed by leaders and scientists with specialized skills in CGT analytical development, bringing together a wealth of experience from major biopharmaceuticals, biotech, CDMOs, and CROs. Our comprehensive services offer a ‘one-stop-shop’ experience, covering everything from analytical assay development to qualification and validation, all within a single facility. Our state-of-the-art laboratory spans over 2000 square feet, adhering to GLP/GMP standards, and is equipped with advanced instruments for efficient assay development.

Frontage has developed a robust approach to drug development, accommodating technology transfer and assay development for drug products and substances. We also provide platform assays to ensure drug products and substances’ safety, potency, stability, strength, and purity. We look forward to exploring how our expertise can enhance and expedite your drug development program.

Request a quote for analytical development needs of your cell or gene therapy products.

Cell Therapy Capabilities

Cell therapy represents a groundbreaking frontier in modern medicine. Our role is to lead the way in maximizing its potential benefits for your team. Our comprehensive services for autologous, allogeneic, and gene-mediated cell therapies encompass integrated analytical development and routine testing. This portfolio is designed to facilitate swift progression into clinical trials.

Cell Therapy Services

Cell Types for Cell Therapy

  • Chimeric Antigen-Receptor T Lymphocytes (CART)
  • Induced Pluripotent Stem Cell (iPSC)
  • Tumor Infiltrated Lymphocytes (TILs)
  • Natural Killer Cells (NK)

Analytical Tests for Cell Therapy

  • Analytical Method Development
    • Viral Copy Number per Transduced Cells VCN)
    • PBMMK Immunophenotyping
    • CAR-T/ -NK Identity Characterization (%CAR)
    • Process Purity / Impurities Immunophenotyping
    • Drug Product Identity Immunophenotyping
    • Residual Host Cell DNA / Protein
    • Replication of Competent Lentrivirus by ddPCR (RCL)
    • Cell Number and Viability
    • Cell-based Potency via Cytotoxicity or Cytokine Production
  • USP Compendial Methods (pH, Endotoxin, Sterility, Mycoplasma, appearance)
  • Phase-appropriate Assay Verification, Qualification and Validation

Technologies & Platforms

  • ThermoFisher Quant Studio 5, Quant Studio 7
  • BioRad QX200 ddPCR platform
  • Chemometec NC200
  • Molecular Devices Spectramax iD3/M2e readers
  • Beckman Coulter Cytoflex S
  • Beckman Coulter Navios

Gene Therapy Capabilities

Gene Therapy is a key area of progress in biological and clinical research. For developments leading to IND filing, BLA, PMA, and clinical trials, stringent analytical testing is crucial for validating product parameters and descriptors. Frontage Laboratories, acknowledging this essential need, provides a wide range of Gene Therapy Services designed to meet varied client testing demands. With over five years of expertise in analytical development, methods qualification and validation, and sample testing, Frontage has propelled client products forward and played a significant role in their success.

Gene Therapy Services

Modality Type for Gene Therapy

  • Retrovirus, including lentiviral vector (LVV)
  • Adeno-associate virus (AAV)
  • Adenovirus (AdV)
  • Gene Editing
  • Plasmid DNA/Therapeutic DNA/mRNA

Analytical Tests for Gene Therapy

  • cGMP Routine Testing Support
  • Analytical Method Development and Validation Services
    • Genomic Titer
    • Infectious titer/TCID50
    • Capsid Identity (Spectramaxi3D, MSD, Protein Simple)
    • Capsid Primary Sequence and PTM Analysis
    • Empty: Partial: Full Capsid Ratio (AUC, AEX, cIEF)
    • Aggregation (SEC-HPLC, MALLS, DLS, AUC, FFF)
    • Residual Host Cell Protein Analysis/ELISA
    • Residual Host-cell DNA/RNA
    • Genome and Gene Editing Analytics
    • Cell-Based Potency
    • NGS
    • Replication of Competent AAV by ddPCR
    • Replication of Competent LVV by ddPCR
    • R&D Cell Banking Services

Technologies & Platforms

  • NanoDrop Microvolume Spectrophotometers
  • Thermofisher Quant Studio 5, Quant Studio 7
  • BioRad QX200 ddPCR platform
  • Chemometc NC200
  • Molecular Devices Spectramax iD3/M2e readers
  • Beckman Coulter Optima AUC
  • Waters/Agilent – UPLC/HPLC
  • ProteinSimple Maurice CE-SDS
  • Sciex CESI8000

The Frontage Advantage

The Cell and Gene Therapy team at Frontage Laboratories is composed of extremely skilled scientists who focus on quality, collaboration, and service.  Our team of expert scientists will work with you to develop and optimize analytical testing methods for cell and gene therapy methods, products, and other elements of this growing field. Frontage Laboratories can provide help with all your method development, verification, and validation needs for cell and gene therapy testing.

Get in touch with our analytical development team for your cell or gene therapy products.