Product Safety Labs, LLC

Product Safety Labs is an independent contract laboratory in Dayton, New Jersey, established in 1972 and operating from a single site.^[S1][S2][S3] Its centre of gravity is regulatory safety testing for products that go to the Environmental Protection Agency and the Consumer Product Safety Commission as much as to the Food and Drug Administration: pesticides, biocides, industrial chemicals, consumer products and medical devices.^{[S5][S12][S13]} A drug developer will still find familiar work here, including genetic toxicology, repeat-dose studies, reproductive toxicology and a catalogue of rodent pharmacology models.^{[S6][S7][S9][S10]} The reason to read this profile carefully is regulatory fit rather than capability: the same study name means different things under a pesticide guideline and under a pharmaceutical one, and this laboratory works across both.

Services relevant to US drug developers

Toxicology

The toxicology programme covers acute studies by oral, dermal and inhalation routes, eye and skin irritation, skin sensitization by local lymph node assay and by the Buehler and maximization methods, repeat-dose and subchronic studies across several routes, chronic and carcinogenicity study designs, and reproductive and developmental toxicology from screening designs through one- and two-generation studies.^[S5] Guidelines are named for each study type, drawn from the EPA harmonized test guidelines and the OECD test guidelines.^[S5] Repeat-dose study data are captured and reported in a commercial toxicology data system.^[S7] Pathology support includes peer review, pathology design for disease models, and morphological phenotyping of genetically modified animals.^[S8]

Genetic toxicology

The genetic toxicology panel is broad and is presented against OECD test guideline numbers: bacterial reverse mutation, the mouse lymphoma assay, in vitro micronucleus, in vitro and in vivo chromosome aberration, unscheduled DNA synthesis, in vivo micronucleus, the comet assay and the Pig-a assay, among others.^[S6] The company states that the company describes these as GLP studies; for each protocol, confirm whether FDA GLP (21 CFR Part 58), EPA GLP (40 CFR Part 160 or 792) or OECD GLP applies.^[S6] For a pharmaceutical programme, confirm that the battery and the protocol follow the current ICH genotoxicity guidance, and a sponsor should confirm that the protocol is written to that guidance rather than to the chemical-sector equivalent.

Pharmacology models

A catalogue of rodent pharmacology models is published by therapeutic area.^[S9][S10] Cardiovascular models include apolipoprotein E knockout mice, atherosclerosis models, haemorrhage, ischaemia-induced heart failure and septic shock.^[S10] Central nervous system work lists named assays including rotarod, tail flick, hot plate, the Irwin screen, catalepsy and spinal or sciatic nerve ligation.^[S10] Gastrointestinal models include charcoal meal transit, gastric emptying, the pylorus-ligated rat and induced emesis in the ferret, and inflammation models include adjuvant arthritis, carrageenan paw oedema, collagen-induced arthritis and dextran sulfate sodium colitis.^[S10] Metabolic models are diet-induced obesity in the C57BL/6J mouse, dyslipidaemia models and the non-diabetic Zucker fatty rat.^[S10] Routes of administration include oral, intravenous, intramuscular, intraperitoneal, subcutaneous, oral film and dermal patch, with bioanalysis by liquid chromatography with mass spectrometry or ultraviolet detection and by immunoassay.^[S9] These are animal models; results in them describe the model and do not establish that a compound will work in people.

Analytical chemistry and device testing

Analytical support is provided in house, covering dose concentration determination, method development and validation, stability evaluation and inhalation atmosphere analysis, using liquid and gas chromatography, mass spectrometry and inductively coupled plasma instrumentation.^[S4][S11] For medical devices, biological safety testing is offered to the ISO 10993 series, including chemical characterization of extractables and leachables to ISO 10993-18.^[S12] Those standards are cited as testing standards; no laboratory accreditation to a quality standard such as ISO 17025 was found on the pages reviewed.

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

Product Safety Labs names the specific regulations its quality assurance unit works to, as listed by its quality assurance unit. The list given is the FDA good laboratory practice regulation at 21 CFR Part 58, the EPA good laboratory practice standards at 40 CFR Part 160 under the pesticide statute and at 40 CFR Part 792 under the toxic substances statute, the OECD principles of good laboratory practice.^[S4] The company names 21 CFR Part 58, 40 CFR Part 160, 40 CFR Part 792, the OECD principles, the in its GLP statement.^[S4] 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 the regulations makes the confirmation step easier, because the question becomes which of the listed regulations a given study will follow rather than whether any applies.

On animal work, the company states that it is AAALAC accredited and USDA registered, and that its vivarium has 28 animal rooms with dedicated necropsy and surgical rooms and an isolated cage wash area.^[S3][S5] No Animal Welfare Assurance with the Office of Laboratory Animal Welfare and no reference to an Institutional Animal Care and Use Committee were found on the pages reviewed. An OLAW Animal Welfare Assurance is required for institutions engaged in activities involving animals that are conducted or supported by the Public Health Service.^[R5], so its absence is not necessarily meaningful for privately funded contract work, but a sponsor whose funding carries that condition should ask. 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] The company also states that its quality assurance unit hosts audits by sponsors and by FDA and EPA, and describes its audit record as outstanding.^[S4][S5] That characterization is the company own; audit outcomes are not published, and FDA does not approve or certify laboratories.^[R6]

Two of the company own claims are worth reproducing with attribution rather than adopting. It describes itself as conducting comparative marketing claims about its volume of acute studies,^[S13] and as comparative marketing claims about its pharmacology testing.^[S9] Neither claim could be checked against an independent source, and this site does not rank laboratories. They are recorded here as statements the company makes about itself.

One practical caution concerns the currency of the published information. The site footer carries a 2020 copyright date, the site footer displayed a 2020 copyright date when reviewed, and several pages carry no date.^[S1] Descriptions of capacity, equipment and staffing on a site in that condition should be confirmed directly before they are relied on.

Company facts