Pacific BioLabs is a testing laboratory in Hercules, California. It describes itself as "an independent CRO offering cGMP/GLP testing services in in vivo services, biocompatibility, pharmacology, analytical chemistry, and microbiology."[S17] The reviewed pages emphasise safety and quality testing. No disease model catalogue, safety pharmacology package or infectious disease research line was found on those pages: no disease model catalog, safety pharmacology package or infectious disease research line was found on the pages reviewed. One commercial point matters from the outset: the company applies GLP when a client requests it, not by default.[S5] This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug and device developers
Medical device biocompatibility and sterility assurance
For medical devices the company lists in vivo biocompatibility, USP Class Plastics testing, material-mediated pyrogenicity and contact lens solution testing.[S8] Its microbiology and sterility assurance line covers cleaning and disinfection validation, sterilization validation, shelf life testing, limulus amebocyte lysate and pyrogen testing, bioburden and sterility testing, and environmental monitoring.[S9] Parallel sterility, microbial limits and USP water testing lines support pharmaceutical manufacturing.[S12]
Analytical chemistry, bioanalysis, and in vitro assays
Analytical work covers chemical characterization, ICH stability testing, trace elemental analysis by ICP-MS, biosimilar development support, pharmacokinetic bioanalysis, biomarker analysis, and method development and validation. The company states that it "offers several platforms (HPLC/UV, LC/MS, GC/MS, GC/FID, ELISA) for analysis"[S10] and publishes a partial list of validated compounds and methods.[S10] For clinical trials it offers immunogenicity and neutralizing antibody assays and PK bioanalysis.[S11] In May 2022 it announced an in vitro cell-based assay group, stating the "launch of In Vitro Services offering in vitro, cell-based assays supporting the pharmaceutical, biopharma, and medical device industries,"[S13] covering cytotoxicity, proliferation, apoptosis, hemolysis, angiogenesis, reporter and cytokine release assays.[S13]
In vivo work and the facility
The company runs in vivo pharmacokinetic, toxicokinetic, toxicology and custom studies at its own vivarium. It describes "a stunning 32,000 square foot facility in Hercules, CA"[S4] whose "vivarium contains 26 animal rooms (including a separate suite for SPF rodents) along with contiguous laboratory spaces,"[S4] alongside "a mass spec lab with five mass spec instruments, an HPLC suite containing a dozen instruments, and a stability chamber room with six large chambers."[S4] The reviewed website identifies the Hercules facility; confirm whether work may be assigned to any other operating site; an 18,000 square foot expansion is mentioned on the same page.[S4] Species and strain detail is not broken out on the service pages, which are organized by study type and standard rather than by species.
Quality and compliance (as stated by the company)
The company states that it performs testing under GLP when the client requests it. The company states plainly: "Pacific BioLabs will perform testing in accordance with GLPs when requested by the client."[S5] Its regulations page names both FDA GLP at 21 CFR 58 and EPA GLP at 40 CFR 160 as the applicable regulations, alongside cGMP at 21 CFR 210, 211 and 610 and the medical device quality system regulation at 21 CFR 820.[S7] The baseline quality system is cGMP rather than GLP: the company states that it "operates (and has been operating since 1982) a Quality System designed to achieve compliance with the Current Good Manufacturing Practices (cGMPs) at a minimum."[S6] Sponsors should therefore state in writing at the quotation stage whether a study is to be run to GLP, since the company describes this as a client-requested option carrying an additional charge, and should confirm which regulation applies.[R2]
Accreditation and registration. In June 2024 the company announced that its ISO/IEC 17025 accreditation would be administered by A2LA as a testing laboratory, announcing in June 2024 that "our ISO 17025 accreditation is now being managed and overseen by the American Association for Laboratory Accreditation (A2LA)."[S15] ISO/IEC 17025 accredits testing competence for a defined scope; it is not a management system certification such as ISO 9001 or ISO 13485, and it is not equivalent to GLP. On animal work, a July 2021 post states that the company "initially obtained AAALAC accreditation in 2008 and has successfully received renewal accreditation since that time,"[S14] and a 2013 post records an annual USDA facility inspection with no findings and names the company's IACUC.[S16] The site footer displays an FDA registration badge.[S1] Registration is not approval, and the compliance page states that "we are routinely inspected by the FDA and auditors from many of our clients."[S5] No OLAW Animal Welfare Assurance, CLIA or GCLP statement was found on the pages reviewed. 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]
Company facts
Name
Pacific BioLabs (no corporate suffix is shown on the website)[S1]
Headquarters
551 Linus Pauling Drive, Hercules, CA 94547, United States[S2]
Founded
1982 as Northview Pacific Labs, the West Coast division of Northview Biosciences (founded 1972); renamed Pacific BioLabs in 2006[S3]
Ownership
Private and independent; spun out from Northview Biosciences in 2006 retaining the same family ownership[S3]
Facility
32,000 sq ft, including a vivarium with 26 animal rooms and a separate SPF rodent suite[S4]
Employees and revenue
Not published
Service scope
Biocompatibility, sterility assurance and microbiology, analytical and bioanalytical chemistry, in vitro cell-based assays, in vivo toxicology and PK, manufacturing QC support. No disease model efficacy, safety pharmacology or infectious disease service line was found on the pages reviewed; that is an absence in those pages, not a finding that none exists[S8][S9][S10][S13]
GLP
Applied when requested by the client, for an additional charge; FDA 21 CFR 58 and EPA 40 CFR 160 named[S5][S7]
Baseline quality system
cGMP since 1982 (21 CFR 210, 211, 610); medical device QSR 21 CFR 820 used as an additional requirements matrix[S6][S7]
Laboratory accreditation
ISO/IEC 17025:2017, administered by A2LA since June 2024[S15]
Animal welfare
A July 2021 company post stated that AAALAC accreditation was first obtained in 2008 and had been renewed through that date; confirm the current status; IACUC named in a 2013 USDA inspection post; animal housing described as USDA inspected[S14][S16]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise
In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
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