Pacific BioLabs – A Bay Area CRO Testing Large Molecules, Small Molecules, and Medical Devices
Pacific BioLabs is a contract research organization (CRO) offering testing and research support services primarily focused on supporting the pharmaceutical (small molecules), biopharma (large molecules), and medical device industries. As a CRO specializing in microbiology, in vivo services, analytical chemistry, and cell-based in vitro bioassays, 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 40 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
Pacific BioLabs is committed to being The Service Leader in Life Science Testing. 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
Pacific BioLabs is FDA registered. We are an ISO 17025:2017 accredited testing lab certified for microbiology, in vivo services, analytical chemistry testing services. 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 Life Science Testing.
Areas of Expertise
Pharmaceutical and Biologic Manufacturing Support
Biological Reactivity of Materials
Identity and Purity – Small Molecules
Identity and Purity – Large Molecules
Extractable Leachable Testing (USP 661)
Clean Room Environmental Monitoring
USP Water Testing (TOC, Conductivity, Heterotrophic Plate Count)
Pharmaceutical and Biologic Development Support
Pharmacokinetics and Toxicokinetics
Method Development and Validation
Antimicrobial Effectiveness Testing
Minimum Inhibitory Concentration
Clinical Trial Support
Medical Device Testing
Material Mediated Pyrogenicity
Contact Lens Solution Testing In Vivo
Contact Lens Solution Testing – Microbiology
Reusable Device Cleaning and Disinfection Validations
Bioburden and Sterility Testing