Biologics Gene & Cell Therapy

Cell & Gene Therapy Services

Biologics Gene & Cell Therapy

Fast-tracking your workflow for safe and effective delivery to market.

Cell Therapy Analytical Services

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 IND-enabling analytical development and routine testing.

This portfolio is designed to facilitate swift progression into clinical trials. 

Analytical Services

  • Analytical Method Development
    • Viral Copy Number per Transduced Cells (VCN)
    • PBMNK Immunophenotyping
    • CAR-T / NK Identity Characterization (%CAR)
    • Process Impurities Immunophenotyping
    • Residual Host Cell DNA
    • Replication – competent Lentiviral by ddPCR (RCL)
    • Replication – competent Adeno-associated Virus (rcAAV)
    • Cell Number and Viability
    • Cell-based Potency via Cytotoxicity or Cytokine Production
  • USP Compendial Assays: Endotoxin (Endosafe), Sterility, Mycoplasma (Mycoplasma PCR)
  • Phase-appropriate Assay Qualification and Validation

Technology Equipment

  • Quant Studio 5, Quant Studio 7
  • QX200 ddPCR Platform
  • NC200
  • Spectramax iD3 Reader
  • Spectramax M2e Reader
  • MSD
  • Beckman Coulter Cytoflex S
  • Beckman Coulter Navios
  • ELISPOT/FluoroSpot

Cell Therapy Experience

  • Adenovirus (Ad) CAR-T / NK
  • Gene-modified NK
  • γδ T cell
  • Tissue Infiltrated Leukocyte (TIL)
  • iPSCs-NK, Macrophage
  • MSCs w/ or w/o gene editing

Gene Therapy Analytical Services

Gene Therapy is a key area of progress in biological and clinical research. For developments leading to IND filing, BLA, and clinical trials, stringent analytical testing is crucial for validating product parameters and descriptors.

Acknowledging this essential need, Frontage 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. 

Analytical Services

  • cGMP Manufaocturing Routine Testing Support
  • Analytical Method Development and Validation Services
    • Capsid Primary Sequence and PTM Analysis
    • Host Cell Protein Analysis/ELISA
    • Residual Host-cell DNA/RNA and Helper Plasmid Analysis
    • Empty/Full Vector Partical Analysis
    • Vector Genome Analysis
    • Genome and Gene Editing Analytics
    • Gene Expression Analysis
    • NGS
  • Plasmid DNA Testing
  • Virology Service in BSL-2+ Laboratory

Technology Equipment

  • Titer (q-PCR, ddPCR), Infectious Titer (TCID50)
  • Empty: Full Capsid Ratio (AUC, AEX, cIEF)
  • Capsid Serotype (Spectramax iD3, MSD, Cytation System, Protein Simple)
  • Aggregation (SEC-HPLC, MALS, DLS, AUC)
  • Impurities (UPLC, HPLC, ELSD, CAD, LC/MS)
  • Potency (Cell-Based Assays)
  • Cell Line Design (Cell Culture Lab)
  • USP, Sterility (Bac-T, Endosafe)
  • Viral Product Characterization (cIEF, CE-SDS, HPLC and LC-MS/MS)

Gene Therapy Experience

  • Adenovirus (Ad)
  • Adeno-Associated Virus (AAV)
  • Custom Recombinant Viruses
  • Producer Cell Line Systems
  • Platform Analytical Methods for Development and Quality Control
  • PTM Characterization Assays
  • MoA-Based Potency Assays