BioIVT

BioIVT supplies control and disease-state human and animal biospecimens, including tissues, cell products, blood and other biofluids, collected under IRB-approved protocols. It also runs ADME, DMPK and drug-drug interaction studies, bioanalysis and in vitro assay services, with scientific consulting for drug discovery and development teams.

Biospecimens

• Supply human biospecimens from inventory or as custom collections shipped overnight to specification, sourced through a clinical network of over 200 sites, including disease-state biofluids, tissues and access to over 200,000 curated FFPE tissue blocks.
• Supply animal whole blood, plasma and serum, such as Göttingen Minipigs®, rabbit and mouse, with a choice of anticoagulant, aliquot size, volume and shipping temperature.
• Provide DNA, RNA and other molecular extractions from human and animal tissues, and Visionaire™ biospecimen data: curated biospecimens with clinical data, NGS, H&E and IHC images and biomarker information, starting with oncology cohorts.

Cell Products and Research Materials

• Supply primary and iPSC-derived cells from human and preclinical species, with over 50 cell products ready to ship, including hepatocytes (fresh or cryopreserved, suspension or plateable, and HEPATOPAC co-cultures) and PBMCs.
• Supply media, sera, reagents and kits, including ADME media, control CYP substrates and their metabolites, and RUO and GMP cell culture grade human AB serum.

ADME, DMPK and DDI Studies

• Design, run and interpret in vitro ADME, DMPK and DDI programs covering CYP inhibition, metabolic stability and transporters, to precede first-in-human trials or supplement clinical data.
• Plan and manage in vivo ADME and PK studies, including radiolabeled ADME, with its partner the Drug Development Solutions Center.
• Develop and validate bioanalytical methods and profile metabolites for small-molecule drugs using triple quadrupole and QTrap mass spectrometers.

In Vitro Assays

• Run metabolic and liver disease assays for diabetes and obesity candidates, skin biology and phototoxicity assays on full thickness skin and 3D skin equivalents, exosome cell-based assays and flow cytometry studies.

Scientific Consulting

• Review preclinical and clinical data to deliver ADME strategies, gap analyses, due diligence, technical writing and preparation for advisory board meetings.

Best Fit

• Discovery, preclinical and translational teams sourcing human or animal biospecimens, hepatocytes, PBMCs or other primary cells.
• Teams that want in vitro ADME, DDI, bioanalysis or specialized assays run by the supplier of their test systems.