BIOLOGICS & GENE THERAPY
Absorption Systems is a GLP/GMP facility offering support from early drug discovery through Phase IV clinical trials. With a core competency in assay development and validation, the AS team routinely creates robust methodologies for compound screening, product characterization, PK/PD analysis, biomarkers such as cytokines/chemokines, potency, stability, and immunogenic response (ADA, NAb).
Complementing the comprehensive array of bioanalytical and bioassay services, the AS facility includes a research-use only vivarium suitable for housing mice, rats, hamsters, and guinea pigs. While providing flexibility in the execution of customized designs for a Sponsor, the AS in-life team routinely performs PK and immunogenicity studies.
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.
Drug Discovery & Development Services
Biologics & Gene Therapy 𝘐𝘯 𝘝𝘪𝘷𝘰 Services
In vivo studies using preclinical models are critical throughout biologic development, from early PK/PD studies to GLP-approved safety and efficacy programs. Maximising insight requires expertise in the models, surgical techniques […]Bioassay Testing Services
Absorption Systems provides the Pharmaceutical, Biotechnology and Academic communities a comprehensive range of analytical lab services in support of basic research and development as well as for clinical studies. We […]Immunoassay Testing Services
Immunoassay testing is a highly selective bioanalytical method that measures the presence or concentration of analytes ranging from small molecules to macromolecules in a solution. Understanding when and how to […]Sample Management
We recognize the importance of maintaining the integrity of your samples, so we go to great lengths to maintain the proper sample chain of custody. Sample storage (ART, 4C, -20, […]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 […]Bioanalytical Testing Services
Navigating regulatory requirements for bioanalytical testing can be challenging and time-consuming. Absorption Systems’ bioanalytical experts will provide you with complete study support, from custom method development through validation and sample […]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 […]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 […]Biodistribution & Shedding Assay Services
Cell and gene therapy development requires a comprehensive understanding of the unique aspects of these products in relation to their in vivo safety profiles. Biodistribution and viral shedding assays are […]