PBL staff has performed antimicrobial effectiveness tests for over ten years.

Choosing PBL as Your CRO

Choosing a contract research organization (CRO) can be a difficult and time consuming task.  A poor decision could lead to lost time, wasted money and even FDA intervention.  There is no single CRO that would be a perfect fit for every project.  Time needs to be taken to understand what type of tests and procedures the CRO excels at and there should be a clear understanding about CRO’s history performing the testing you need in the regulatory environment that is required.  Pacific BioLabs has been a CRO performing regulatory testing for over 40 years. PBL opened a San Francisco Bay Area facility in 1982.  Our experience, dedication to client service and our commitment to quality is unparalleled.

PBL Quality

When the lives and health of patients depend on the results of a CRO’s work, a rigorous, thorough, and systematic approach to quality is absolutely necessary.

The quality systems and procedures at Pacific BioLabs are verified through internal audits, client audits, FDA inspections, the EPA, EMA, MHRA, and ISO 17025 accrediting and certification bodies. We think the results speak for themselves:

  • ISO 17025 Accreditation
  • Over 50 Client Audits per year
  • cGMP and GLP compliant
  • AAALAC accredited

PBL has hundreds of protocols and standard operating procedures covering everything from calibration, to document control, to testing services. All employees are given training on the PBL approach to quality, both as new hires and on an ongoing basis.

PBL Service

We think service is much more than just being friendly on the phone. To us, exceptional service means providing testing of the highest quality, delivering timely results, and, of course, making every effort to be not only friendly people, but the kind of people who proactively seek out solutions for your needs. Altogether, this means that you can have confidence in the results and data that we deliver to you.

We believe that every client deserves this level of service. That’s why delivering exceptional service forms the core of what we do here at PBL, and it’s why we strive to be The Service Leader in Life Science Testing.

PBL Reliability

With over 40 years of experience providing contract research services to companies ranging from medical device startups to global pharmaceutical corporations, PBL’s consistent and reliable results have helped thousands of products reach the market.  PBL is the CRO that companies of all sizes use when they need a reliable lab that delivers reports on time and on budget while putting the client first.

In a typical year, Pacific BioLabs performs approximately 10,000 studies. It is this established history of experience and production that you can rely upon when working with PBL.

Location – Centrally Located in the Bay Area

Situated in the San Francisco, California Bay Area – the world’s leading biotech hub – Pacific BioLabs is in an ideal location to serve not just the California and US life science markets, but international clients as well. The extensive local life sciences sector, as well as our proximity to Universities such as UC Berkeley, Stanford, and UC Davis make it easy to find exceptional scientific talent.

We welcome clients both current and prospective to visit our facility in the beautiful San Francisco Bay Area, and learn why PBL is the right CRO for you.

Areas of Expertise

Pharmaceutical and Biologic Development Support

In Vivo Services 

Pharmacokinetics and Toxicokinetics

PK Bioanalysis

Custom Studies

Cytotoxicity

Stability Studies

Biosimilar Development

Characterization of NCEs

Biomarker Analysis

Metabolite Identification

Method Development and Validation

Antimicrobial Effectiveness Testing

Time Kill Testing

Minimum Inhibitory Concentration

Pharmaceutical and Biologic Manufacturing Support

Insulin Bioassays

Glucagon Bioassays

Botulinum Toxin Testing

Somatotropin Bioassays

Safety Tests

Biological Reactivity of Materials

Pyrogenicity

Identity and Purity – Small Molecules

Identity and Purity – Large Molecules

Raw Material Testing

Physicochemical Properties

Cytokine Testing

In Vitro Potency Assays

Extractable Leachable Testing (USP 661)

Cytotoxicity

LAL and Pyrogen Testing

Microbial Limits Test

Sterility

Clean Room Environmental Monitoring

USP Water Testing (TOC, Conductivity, Heterotrophic Plate Count)

Container Integrity Testing

Clinical Trial Support

BoNT Mouse Protection Assay

Immunogenicity Testing

PK Bioanalysis

Biomarker Analysis

Medical Device Testing 

Biocompatibility

USP Class Plastics

Material Mediated Pyrogenicity

Contact Lens Solution Testing – In Vivo

Contact Lens Solution Testing – Microbiology

Chemical Characterization

Latex Testing

Residual Testing

Complement Activation

Reusable Device Cleaning and Disinfection Validations

Sterilization Validations

Device Shelf-Life Testing

LAL and Pyrogen Testing

Bioburden and Sterility Testing

Environmental Monitoring

Cytotoxicity

Package Integrity Testing

Instrumentation Expertise

ICP-MS

TOF-MS

GC-MS

LC-MS/MS

HPLC

GC

MSD

Pacific BioLabs