Pacific BioLabs, Inc.

What Pacific BioLabs, Inc. does

Pacific BioLabs, Inc. (PBL) is a privately held, family-owned contract research organization (CRO) headquartered in a 32,000-square-foot purpose-built facility in Hercules, California. Founded in 1972 by Martin Spalding, Sr. as Northview Biosciences, the West Coast operations (Northview Pacific Labs) were spun out as an independent entity in 2006 and renamed Pacific BioLabs, retaining Spalding family ownership. The company has operated continuously for over 40 years in the life science testing industry and performs approximately 10,000 studies annually for pharmaceutical, biopharmaceutical, and medical device manufacturers worldwide. Current leadership includes CEO Michael Spalding and COO Mike Yakes, with continued family involvement and no institutional investment, private equity, or venture capital backing.

The company delivers a comprehensive portfolio of cGMP/GLP-compliant testing services organized into five core categories: Pharm/Biopharm Manufacturing Support, Pharm/Biopharm Drug Development Testing, Clinical Trial Support, Medical Device Tests, and In Vitro Services. Technical capabilities span in vivo toxicology (including insulin, glucagon, and botulinum toxin bioassays per USP standards), analytical and bioanalytical chemistry (HPLC, LC-MS/MS, GC-MS, ICP-MS, ion chromatography, Orbitrap mass spectrometry), microbiology (LAL/pyrogen, sterility, microbial limits, environmental monitoring), and cell-based in vitro assays (cytotoxicity, cytokine, potency, proliferation, apoptosis, hemolysis). The Hercules facility houses a vivarium with 26 animal rooms, dedicated mass spectrometry and HPLC suites, six stability chambers, and capacity for an 18,000 sq ft expansion. Pacific BioLabs is implementing STARLIMS Laboratory Information Management System technology with Laboratory Execution System and Electronic Lab Notebook modules to transition to a paperless laboratory environment with optimized workflows.

The business operates on a professional services / contract research model with quote-based pricing for individual studies. Customer acquisition occurs through direct enterprise sales supported by dedicated Client Account Managers, complemented by an online client portal (MyPBL) for managing reports, study status, invoices, and purchase orders. The company serves pharmaceutical giants, biotech startups, and medical device manufacturers, conducting over 50 client audits per year. Quality and regulatory credentials include FDA registration, ISO 17025:2017 accreditation (now managed by A2LA), AAALAC accreditation, and a regulatory inspection track record covering FDA, EPA, EMA, and MHRA. The company participates in major industry events (SOT TOXExpo, MEDevice Boston, MEDevice Silicon Valley, MD&M West), runs an educational Learning Center, and was featured on PBS's 'Viewpoint with Dennis Quaid' series in May 2025.

Name

Pacific BioLabs, Inc.

Legal name

Pacific BioLabs, Inc.

Website

https://pacificbiolabs.com

Company type

Private

Founded year

1972

Operating status

Operating

Headcount range

101–250 employees

Short description

Pacific BioLabs is a privately held, family-owned contract research organization (CRO) that performs approximately 10,000 cGMP/GLP-compliant studies annually for pharmaceutical, biopharmaceutical, and medical device manufacturers from its Hercules, California headquarters.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Testing Services

NAICS

Scientific Research and Development Services (5417), Testing Laboratories and Services (54138), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

akta.pro secondary industries

Microbiology & Infectious Disease Testing (Trial Support) (HLAGAEAF), Bioanalytical Testing (PK/ADA/NAb) (HLAGADAA), Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC), Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF)

Keywords

• Contract research services
• Microbiology testing services
• Analytical chemistry testing
• Medical device testing
• Pharmaceutical testing services

Headquarters

HQ city

Hercules

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. Contract Research and Testing Services: Pacific BioLabs generates revenue through providing contract research organization (CRO) testing services to pharmaceutical, biopharma, and medical device companies. Services include microbiology testing, in vivo toxicology studies, analytical chemistry, and bioanalytical services. The company performs approximately 10,000 studies annually across various testing categories including lot release testing, preclinical studies, stability testing, and regulatory compliance testing. Revenue is project-based with quotes provided for each service request.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Pacific BioLabs is a contract research organization that provides cGMP- and GLP-compliant testing services to pharmaceutical, biopharmaceutical, medical device, and biotechnology companies. Its offerings span microbiology testing, in vivo toxicology and bioassays, analytical and bioanalytical chemistry, and cell-based in vitro bioassays, delivered from a 32,000 sq ft purpose-built facility in Hercules, CA. The company performs roughly 10,000 studies annually and supports clients from raw material testing and lot release through preclinical toxicology, clinical trial bioanalysis, and regulatory submission testing.

Product overview

Pacific BioLabs is a contract research organization (CRO) offering a comprehensive portfolio of testing services organized into five core service areas: Pharm/Biopharm Manufacturing Support, Pharm/Biopharm Drug Development Testing, Clinical Trial Support, Medical Device Tests, and In Vitro Services. These services are delivered through specialized departments including In Vivo Services, Analytical/Bioanalytical Chemistry Services, and Microbiology Services. The company also provides a client-facing web portal (MyPBL) for accessing reports and managing studies. Testing capabilities span microbiology, in vivo toxicology, analytical chemistry, and cell-based in vitro bioassays, with operations conducted under cGMP and GLP compliance.

Differentiator

Problem solved

Functional benefit

Brands

• MyPBL: PBL's customer portal allowing clients to view reports, study status, invoices, and access quotes and purchase order information.

Products and services

• Pharm/Biopharm Manufacturing Support

Quantifiable outcome

• Approximately 10,000 studies performed annually
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered core and minor.

• West Coast Device Alliance (WCDA)coreStrategic or Co-development Partner · 8 February 2024Pacific BioLabs joined the newly formed West Coast Device Alliance (WCDA), a strategic partnership comprised of leading California-based companies in the medical device ecosystem.
• SteriTekcoreStrategic or Co-development PartnerSteriTek is one of the most advanced E-beam and X-ray irradiation sterilization, material modification and R&D collaboration facility in North America. Pacific BioLabs collaborates with SteriTek on sterilization cycle validation, including joint webinars and R&D collaboration for medical device manufacturers.
• MicroriteminorImplementation/ SI/ Consulting PartnerMicrorite provides consulting and training services in microbiology, aseptic technique, QC/QA, process development and validation, and equipment validation. Partnership provides supplementary expertise for clients requiring additional consulting support.
• Del BiopharmaminorStrategic or Co-development PartnerDel Biopharma provides innovative strategies to biopharmaceutical organizations of all sizes from established and fully integrated companies to start-ups looking for proof of concept.
• San Jose BiocubeminorStrategic or Co-development PartnerThe BioCube in San Jose, CA provides flexible office space, access to state-of-the-art lab facilities, and business support to promising life science, nanotech, and cleantech startup companies.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Charles River Laboratories: Global CRO providing preclinical toxicology, in vivo bioassays, microbiology, and analytical chemistry services to pharma/biopharma. Closest direct peer to PBL's core safety assessment and manufacturing support offerings, but at significantly larger scale and global geographic footprint.
• Inotiv: Mid-market preclinical CRO and research services provider offering toxicology, safety assessment, and analytical services to pharma/medical device clients. Highly comparable in size and service mix to PBL, and representative of the kind of platform a sponsor-backed CRO rollup would target.
• Celerion: Contract research organization specializing in early-phase clinical research, bioanalytical services, and PK/PD studies. Directly comparable to PBL's clinical trial support and bioanalysis service lines, with similar mid-market positioning serving pharma and biotech clients.
• Frontage Laboratories: CRO offering bioanalytical, preclinical, CMC, and clinical research services to pharma/biopharma. Comparable service portfolio to PBL across analytical chemistry, PK studies, and manufacturing support, with broader US-China operational footprint.
• Pace Analytical: Mid-market commercial testing laboratory providing analytical chemistry, microbiology, and environmental testing services. Comparable mid-tier positioning with similar fee-for-service testing model and emphasis on regulated, accredited laboratory services.

Broad incumbents

• Eurofins Scientific: Global leader in bioanalytical, microbiological, and pharmaceutical product testing services. Overlaps with PBL's microbiology, sterility, and analytical chemistry offerings as part of a much broader testing portfolio across food, environmental, and life sciences.
• WuXi AppTec: Global CRO/CDMO providing preclinical toxicology, bioanalytical, and laboratory testing services across the drug development lifecycle. Directly comparable service lines to PBL but with vastly larger scale and integrated discovery-to-manufacturing platform.
• SGS: Global testing, inspection, and certification company with a life sciences division providing pharma testing, microbiology, and analytical services. Notably, SGS acquired Northview Biosciences' Northbrook and Spartanburg facilities in 2006 — the sister facilities to PBL — making it a particularly relevant historical peer.
• Labcorp (Fortrea): Major clinical and preclinical CRO (spun off from Labcorp) offering bioanalytical, central lab, and early development services. Overlaps with PBL's clinical trial support, bioanalytical, and immunogenicity services at much larger scale and global footprint.
• Intertek: Global testing, inspection, and certification company with life sciences / pharmaceutical services including extractables/leachables, biocompatibility, and analytical chemistry — directly comparable to PBL's medical device and chemical characterization capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xlinkedin.com/company/pacific-biolabs
• LinkedInlinkedin.com/company/pacific-biolabs

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pacific BioLabs, Inc.