MB Research Laboratories

MB Research Laboratories is a contract laboratory in Pennsylvania that describes itself as "a leading Contract Research Organization (CRO) based in Pennsylvania, specializing in short-term toxicology and pharmacology testing services since 1972."^[S2] Its work sits at the hazard identification end of safety assessment: acute toxicity, eye and skin safety, genotoxicity and medical device biocompatibility, with a catalogue of validated in vitro alternative methods alongside the animal tests. No disease model efficacy, safety pharmacology, DMPK or bioanalysis service was found on the reviewed capabilities page; that is not a finding that none exists.^[S10] This profile summarizes the services, stated compliance information, and company facts most relevant to US sponsors.

Services relevant to US drug and device developers

Acute toxicology and genotoxicity

The regulatory toxicology line covers acute oral toxicity under OECD Test Guideline 425, acute dermal toxicity under OECD 402, acute inhalation toxicity under OECD 403 and EPA OCSPP 870.1300, and an acute battery the company calls the Acute Six-Pack.^[S4] It states that "studies are conducted in accordance with OECD, EPA OCSPP, FDA, and ISO 10993 guidelines, with audited final reports typically delivered within 3 - 4 weeks."^[S4] Genotoxicity is offered through the Ames test, which the company describes as "OECD Test Guideline (TG) 471, commonly known as the Ames Test... a cornerstone in genetic toxicology."^[S8] Species and test systems named across the site are guinea pig, rabbit and rat, together with bovine and porcine tissue for ex vivo methods and rodent and human cell lines for in vitro work.^[S9]

In vitro alternative methods

The catalogue of validated non-animal methods is tied to specific OECD guidelines, and each is tied to a specific OECD guideline: the EpiOcular eye irritation test under OECD 492, EpiDerm skin corrosion under OECD 431 and skin irritation under OECD 439, the bovine corneal opacity and permeability test under OECD 437, Corrositex under OECD 435, the 3T3 neutral red uptake phototoxicity test under OECD 432, and the human cell line activation test and related skin sensitization methods under the OECD 442 series.^[S6][S7] The company also offers human-derived three-dimensional tissue models, describing them as "in vitro replicas of specific tissues (e.g., skin, oral, cornea, airway, intestinal) that mimic key structure and function."^[S7] For eye and skin hazard it describes combining in vitro and ex vivo methods in a weight-of-evidence approach.^[S6] Confirm that the selected method and guideline are accepted for the endpoint, the product type and the target submission; that standing is specific to each guideline and should be confirmed against the requirements of the target submission.

Medical device biocompatibility

The company offers a full ISO 10993 battery, stating that it "conducts all biocompatibility tests in accordance with both the US FDA and OECD GLPs."^[S5] Named endpoints cover cytotoxicity under ISO 10993-5 by MEM elution, agar overlay, neutral red uptake, MTT and XTT; sensitization under ISO 10993-10 including the guinea pig maximization test, the Buehler test, the local lymph node assay and the in vitro alternatives; implantation under ISO 10993-6; systemic toxicity under ISO 10993-11; rabbit pyrogenicity referencing ISO/TR 21582; irritation under ISO 10993-23; and genotoxicity under ISO 10993-3.^{[S5] [S5]}

Quality, compliance, and animal welfare (as stated by the company)

GLP with all four standards named. The about page lists the FDA GLP regulation at 21 CFR Part 58, the EPA GLP standards at 40 CFR Part 160 for FIFRA and 40 CFR Part 792 for TSCA, and the OECD Principles of Good Laboratory Practice.^[S2] The company names FDA 21 CFR Part 58, EPA 40 CFR Part 160, EPA 40 CFR Part 792, OECD Principles of GLP in its GLP statement.^[S2] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.^[R2] Naming all four matters for sponsors whose programs span pharmaceutical, agrochemical and industrial chemical submissions, because the applicable GLP regime differs by product type. No ISO management system certification is claimed for the company itself on the pages reviewed; ISO appears in the context of ISO 10993 test standards.

Animal welfare. The company states that its facilities have held AAALAC accreditation since 1975 and that it holds a PHS Approved Animal Welfare Assurance.^[S2] No Institutional Animal Care and Use Committee statement and no use of the 3Rs terminology were found on the pages reviewed, that is an absence in those pages, not a finding about the oversight or policies of the company. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,^[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;^[R4][R5] none of these establishes GLP compliance, which applies to individual studies.^[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.^[R6] This profile does not evaluate the company's animal care program; the statements above are the company's own.

Company facts