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) using the following techniques:
- Flow Cytometry
- Quantitative Western Blot
- Enzyme Activity Assays
- Fluorescent and Luminescent Assays
- Cell Based Assays
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
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.
From RUO Discovery to Fully Validated GxP Bioanalysis Our bioanalytical services expertise provides quantitative measurements on a range of active drugs, from small molecules to peptides, as well as metabolites. We […]Analytical
Potency assay development Infectivity assay Genome titer assay Analytical Tools and Techniques ELISA Validate the commercial kits, assay transfer or develop the test from the scratch (LDT). Can perform Assay […]Biologics & Gene Therapy In Vivo Services
Absorption Systems offers the client a wide range of support for in vivo animal studies for research and clinical applications. Working as an extension of our client’s laboratory, we offer […]