BioIVT

BioIVT supplies the biological material that in vitro work is run on, and also lists laboratory services on its current website. Its catalogue covers human and animal tissues, hepatocytes and other primary cells, peripheral blood mononuclear cells, and biofluids including plasma, serum and leukopaks, in both control and disease states.^[S1][S7][S8] Alongside the catalogue it offers laboratory services: in vitro absorption, distribution, metabolism and excretion programmes, transporter and drug interaction work, bioanalysis, disease models and skin biology assays.^[S4] It is not a general nonclinical contract research organization. No animal efficacy or toxicology programme is described, and the regulatory questions a sponsor should ask here are different from the ones asked of an animal facility: they concern how human tissue was obtained and consented, not good laboratory practice.

Services relevant to US drug developers

Biospecimens and primary cells

The company describes itself as providing control and disease-state samples, including human and animal tissues, products for absorption, distribution, metabolism, excretion and toxicity work, and biofluids.^[S1] The published catalogue covers hepatocytes in fresh, cryopreserved plateable and suspension formats from human and animal sources, immune cell subsets, adipocytes, fibroblasts, epithelial, endothelial and muscle cells, keratinocytes, melanocytes, stem cells and dissociated tumour cells, with tissue organized by organ system and offered as microarrays and in named disease states.^[S7][S8] Sourcing is described as running through 29 donor and biospecimen centres worldwide.^[S3] For a sponsor, the practical questions with catalogue material are donor characteristics, lot-to-lot variability, and whether the consent under which the material was collected covers the intended use.

Laboratory services

The service divisions published are in vitro absorption and metabolism programmes, in vivo work described as ADME and pharmacokinetic studies, bioanalysis, disease models, exosome assays and skin biology assays, with supporting offerings in consulting, biospecimen characterization, metabolic disease research and protein degrader work.^[S4] The in vitro programme names drug metabolism, transporter assays, enzyme induction and inhibition, hepatobiliary disposition, hepatotoxicity, reaction phenotyping and metabolite identification.^[S5] A transporter platform publishes more than sixty individually named single-transporter overexpression assays, covering named efflux and uptake transporters; sponsors should map the assays they need to their own development plan.^[S6] The company positions these along a sequence from discovery through lead development to building data packages for a regulatory submission.^[S4] The in vivo service page could not be read even in a browser, so its species, study designs, location and regulatory status are unknown, and a sponsor needing animal work should treat it as an open question rather than a described capability.

Quality and the regulation that actually applies here

A supplier of human tissue is regulated on different grounds from a testing laboratory, and the company quality page reflects that. The credentials it lists by name are standard quality management systems, ethics, informed consent, donor information practices, a United Kingdom Human Tissue Authority licence for human application, a registration with the Food and Drug Administration covering human cells, tissues and cellular and tissue-based products, and quality control procedures for human tissue biospecimens.^[S2] Those are the right categories for this business. Registration with FDA under the tissue rules is a listing requirement, not an approval of the company or its products, and FDA establishment registration does not by itself denote approval, and this profile does not describe the company or its products as FDA approved.^[R6] The headings above were visible on the page; their underlying text was not opened, so the scope and dates of each are not stated here.

No good laboratory practice claim was found, and no AAALAC accreditation, USDA registration or Animal Welfare Assurance appears on the pages reviewed. For material supply and in vitro assays that is unremarkable, since the good laboratory practice regulation applies to nonclinical laboratory studies rather than to reagents,^[R2] and the animal welfare frameworks apply to the care of live animals.^[R3][R4][R5] A sponsor incorporating in vitro data into a submission should still confirm which quality standard the specific assay will be run to, and whether a study report with a compliance statement is required for that endpoint.

Growth by acquisition

The company states plainly that acquisition is its growth strategy, and names recent ones with dates: BeCytes Biotechnologies in October 2025, described as extending its European reach for human tissue; ZenBio in August 2024, adding primary cells and skin and blood-based systems; PrecisionMed in July 2023, described as adding a large private cerebrospinal fluid repository; and XenoTech in September 2022, which is where much of the metabolism and drug interaction capability came from.^[S1] Earlier businesses absorbed into the group are listed elsewhere on the site.^[S8] For a sponsor, the relevant consequence is that a named assay or catalogue line may have originated at a different company, with its own history and documentation, so provenance is worth asking about for anything that will support a filing.

Company facts