About Pacific BioLabs

PBL – A Bay Area CRO

Pacific BioLabs is a contract research organization (CRO) offering testing and research support services primarily focused on supporting the pharmaceutical, biotech, and medical device industries. As a CRO specializing in microbiology, toxicology, analytical chemistry and bioanalysis PBL is committed to helping its clients deliver lifesaving medicines and medical devices to physicians and patients who need them.

Pacific BioLabs has been serving companies worldwide for over 35 years. Our location in the San Francisco Bay Area is ideal for providing close support services to the many life sciences companies located nearby, yet we have the experience and capabilities to serve global companies. Our clients range from small biotech and medical device startups to Fortune 500 pharmaceutical giants.

Exceptional Service and Quality

PBL is committed to being The Service Leader in Bioscience TestingSM. A dedicated staff of scientists, quality professionals and support personnel is at the core of our ability to deliver fast friendly service to all our clients. Our staff is recognized throughout the industry for their experience, technical competence and commitment to service.

We conduct all studies in accordance with applicable Current Good Manufacturing Practice (cGMP) and, when requested, Good Laboratory Practice (GLP) regulations. PBL has an outstanding regulatory track record with numerous successful inspections by FDA, EPA, USDA, and international regulatory agencies. With a strong emphasis on training, PBL’s quality systems are designed to prevent errors. An aggressive internal audit program helps assure the quality of data for our clients and the FDA.

Client input is a key element of our continuous improvement process. We gather client feedback on a regular basis. Client audits are an especially valued source of suggestions for refinements to PBL’s quality systems.

Certifications and Registrations

PBL is FDA registered and ISO 13485:2003 certified by Intertek. Our animal science operations have been accredited by AAALAC. PBL staff members are active in a number of professional societies and trade associations.

PBL’s operations are housed in the state of the art facility overlooking the San Francisco Bay. This facility includes over 30,000 sq feet of laboratory space, offices, and support areas. It provides a modern GMP-compliant testing environment. Just as importantly, it provides a beautiful, clean and safe working environment for the PBL staff.

PBL takes great strides to be an employee-friendly workplace. PBL values the talents and abilities of our employees and seeks to foster an open, cooperative, and dynamic work environment. Without a dedicated staff we can’t succeed in our ambition to be:

The Service Leader in Bioscience TestingSM.

Areas of Expertise

Pharmaceutical and Biologic Manufacturing Support

Insulin Bioassays

Glucagon Bioassays

Botulinum Toxin Testing

Somatotropin Bioassays

Tetracosactide Bioassay

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

Pharmaceutical and Biologic Development Support

In Vivo Toxicology 

Pharmacokinetics and Toxicokinetics

Radiolabeled ADME

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

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

 

 

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