Formally known as TGA BioServices, the Absorption Systems Boston (ASB) team boasts over 20 years of experience supporting efforts from early drug discovery through phase IV clinical trials at the doorstep of the largest pharmaceutical hub in the US.
ASB, widely known for immunoassays, routinely develops and validates complex methodologies to better illustrate pharmacokinetic, pharmacodynamic, and immunogenic responses to a biotherapeutic. ASB has evaluated over 400 unique biomarkers furthering drug discovery in areas including endocrinology, inflammation/immunology, metabolism, and cardiovascular. In regard to regulated assays, just in the last few years ASB validates dozens of methods for GLP or GMP analysis to support clinical trials (PK, PD, ADA, Nab), product and stability release, and determination of contaminants in highly purified products. Supporting a variety of biotherapeutics into the market ranging from orphan diseases to medical devices, ASB has hosted 8 successful audits from the FDA related to both GLP and GMP work and an inspection by the EMA/MHRA.
ASB is also an established leader in the customization of bioassays highlighted through the development of over 30 specialized in-vitro dermal models for product characterization while providing unparallel insight in areas such as wound healing and cytokine release. ASB’s expertise with customized bioassays expands further into biotherapeutic innovations such as supporting the leading regenerative medicine brands in the world. Through rigorous cell purity testing and immunophenotyping of surface markers, ASB provided pivotal testing of drug product for some of the first FDA-approvals for living, human cell-based medical devices.
Although research-use only, ASB’s in-vivo small rodent facility has collaborated with a variety of gene therapy companies maintaining 5 transgenic breeding colonies in the past two years including robust record-keeping and ensuring genetic integrity. With a close proximity to Cambridge, ASB’s in-vivo services are largely related to immunogenicity including the generation of antibodies as well as evaluation of vaccine formulations. However, ASB is also positioned to offer a combination of in-vitro and in-vivo tumor efficacy models and tag therapeutics to evaluate biodistribution through survival, in-vivo imaging.