Cell and Gene Therapy (CGT) Services

In-Vitro Biological Testing

Cell and gene therapies (CGT) represent some of the most advanced and promising areas in modern medicine, but their development is accompanied by unique scientific and regulatory challenges. At MED Institute, we provide tailored services to accelerate the development of cell and gene therapy products, including assistance with product characterization, pre-clinical study design, and regulatory strategy. Our expertise in IND-enabling studies, potency and purity assay development, and compliance with FDA and EMA guidelines ensures that your therapy meets rigorous quality and safety standards. We also support the preparation and submission of regulatory documents and facilitates interactions with agencies to help move your therapy efficiently from bench to bedside.

Cell Model Development

• CRISPR/Cas9 KO Lines
• Overexpression cell models
• Induced pluripotent stem cells

Cell Viability Screening

• MTT/XTT/CCK-8 Assays (In accordance with ISO 10993-5:2009)
• ATP content
• Caspase Activation Assay
• Lactate Dehydrogenase (LDH) Assay      

Microscopic Cell Analysis

Fluorescence Quantification and Sub-cellular Localization

• ASTM F3294-18 Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy
• ASTM F2998-24 Standard Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells

Cell Enumeration

• ISO 20391-1 Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
• ASTM F3716-25 Standard Test Method for Cumulative Population Doubling Analysis of the Proliferation of Vertebrate Tissue Cell Preparations

Cellular Genomics

Gene expression profiling

• RT-PCR
• Custom TaqMan® Assays
• Next Gen Sequencing NGS

Cellular/Protein Characterization

• USP <1046>: Cell and Gene Therapy Products—Identity requirements
• Protein Quantification via colorimetric assay and/or UV-Vis
• Protein detection and quantification by immunoassay
  • ELISA, Western blot, Immunocytochemistry
  • LC/MS Proteomics