CELL AND GENE THERAPY

The FDA requires that all biological products seeking Investigational New Drug Application (IND) or Biologics License Application (BLA) approval must meet prescribed requirements of safety, purity and potency. (Guidance for Industry, Potency Tests for Cellular and Gene Therapy Products, FDA, Center for Biologics Evaluation and Research, January 2011)

Validated Potency Assays are required for

• cGMP-compliant Product Stability Testing
• cGMP-compliant Product Release Testing

The Absorption Systems Difference

Absorption Systems established a specialized division in 2017 to focus on cell and gene therapy services. We have over 20 years of business operating experience developing proprietary assays, utilizing both in vitro and in vivo models, to better predict human outcomes. We combine our skills in cell and molecular biology, assay development and validation, bioanalytical and immunochemical quantitation, statistical analysis and regulatory affairs in a single-source collaboration. Our facilities and studies have been inspected by the FDA, EMA, USDA and AAALAC, with our Quality Systems exceeding industry standards. You can therefore be assured of our commitment to accuracy and reproducibility.

We provide in vitro, in vivo, and analytical support to attain an IND or BLA faster

In Vitro Services

• Potency Release Assays
• Enzyme Activity Assays
• Cell Based Assays
• Neutralizing Antibody Assays
• Stability Assays
• GMP Lot Release Testing
• Cytokine Release & Migration Assays
• Vector Infectivity/Transduction Efficiency
• Proliferation Bioassays using Various Cell Types
• Cell Viability and TCID50 Titer
• Sample Management
• Preclinical and Clinical Bioanalysis

In Vivo Services

• Biodistribution & Shedding
• Toxicology
• Immunogenicity
• Small and Large Animal Models
• Regenerative/Stem Cell Testing
• Full Spectrum Ocular Services
• Custom Animal Models
• Immunocompetent & Immunocompromised Models

Analytical Tools and Techniques

• LC-MS/MS
• ddPCR, qPCR, RT-PCR
• ELISA Assays
• Fluorescent Assays
• Luminescent Assays
• Quantitative Western Blot
• Electrophoresis
• Chromatography
• Flow Cytometry

• Cell and Gene Therapy Ocular Services

  Optimized Ocular Models Focused on Improving Outcomes Absorption Systems offers specialized preclinical in vivo ocular models for cell and gene therapy products. Wild type, genetically modified, immunodeficient, and disease-induced models are […]

• Potency Assay Development

  The preferred method for determining potency is a single, quantitative biological assay. However, due to the complex nature of CGT products, this approach may not always be sufficient. In this […]

• Neutralizing Antibodies

  How are neutralizing antibodies different from binding antibodies? In the case of any virus/bacterial infection, antibodies are generated by B-cells as a part of the humoral immune response of our […]