Pacific BioLabs
Pacific BioLabs is a leading CRO specializing in biocompatibility testing for medical devices, offering comprehensive in vitro, in vivo, and analytical services to ensure product safety and regulatory compliance.
Pacific BioLabs is a premier Contract Research Organization (CRO) dedicated to providing comprehensive biocompatibility testing services for medical devices. They specialize in ensuring that devices and materials are compatible with biological systems, adhering to critical international standards such as ISO 10993. Their expertise spans in vitro testing, including cytotoxicity and extractables/leachables analysis (ISO 10993-18), as well as in vivo testing for skin irritation, sensitization, and implantation. Pacific BioLabs also offers hemolysis testing (ASTM F756) and chemical characterization to support regulatory submissions. With a strong emphasis on quality systems, cGMP/GLP compliance, and continuous improvement, Pacific BioLabs guides manufacturers through the complex process of biocompatibility assessment. They help determine the necessary tests, develop biological evaluation plans (BEPs), and ensure compliance with FDA, EU, and other global regulatory requirements, ultimately prioritizing patient safety.
About
**Who they are**
Pacific BioLabs is a Contract Research Organization (CRO) specializing in life science testing, including comprehensive biocompatibility testing for medical devices.
**Expertise & scope**
* Expertise in biocompatibility testing as defined by ISO 10993 standards.
* Services include in vitro, in vivo, and analytical testing to ensure product safety and regulatory compliance.
* Specializes in cytotoxicity testing (MEM Elution, Agarose Overlay, Direct Contact), extractables and leachables testing, and chemical characterization.
* Offers planning services, including the development of a Biological Evaluation Plan (BEP) to determine necessary tests.
* Provides testing for medical devices, delivery devices, and combination products.
* Supports pharmaceutical and biopharmaceutical manufacturing and drug development with services like ICH stability testing and ICP-MS trace elemental analysis.
**Reputation / proof points**
* FDA registered.
* ISO 17025 accredited.
* Animal science operations accredited by AAALAC.
Pacific BioLabs is a Contract Research Organization (CRO) specializing in life science testing, including comprehensive biocompatibility testing for medical devices.
**Expertise & scope**
* Expertise in biocompatibility testing as defined by ISO 10993 standards.
* Services include in vitro, in vivo, and analytical testing to ensure product safety and regulatory compliance.
* Specializes in cytotoxicity testing (MEM Elution, Agarose Overlay, Direct Contact), extractables and leachables testing, and chemical characterization.
* Offers planning services, including the development of a Biological Evaluation Plan (BEP) to determine necessary tests.
* Provides testing for medical devices, delivery devices, and combination products.
* Supports pharmaceutical and biopharmaceutical manufacturing and drug development with services like ICH stability testing and ICP-MS trace elemental analysis.
**Reputation / proof points**
* FDA registered.
* ISO 17025 accredited.
* Animal science operations accredited by AAALAC.
Additional information
Pacific BioLabs emphasizes a structured approach to biocompatibility testing, beginning with planning. This involves understanding the device materials, manufacturing processes, and sterilization methods. A key step is developing a Biological Evaluation Plan (BEP) to guide the selection of appropriate tests. The company highlights the importance of chemical characterization before proceeding to in vitro and in vivo testing, aligning with ISO 10993-1:2018 guidelines. They offer a Biocompatibility Planning Tool (BioPT) to assist manufacturers in this process. Their services are designed to help clients navigate regulatory requirements and ensure the safety of their medical devices for human use.
Key Highlights
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Specializes in biocompatibility testing for medical devices according to ISO 10993 standards.
Source
“Biocompatibility is, by definition, a measurement of how compatible a device or material is with a biological system. The ISO 10993-1: 2018 standard defines biocompatibility...”
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Offers a range of in vitro tests including cytotoxicity (MEM Elution, Agarose Overlay, Direct Contact).
Source
“Cytotoxicity is a biocompatibility test performed on mammalian cells in culture. There are three in vitro cytotoxicity tests that PBL performs: MEM Elution, Agarose Overlay, and Direct Contact.”
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Performs extractables and leachables testing and chemical characterization, often prior to in vivo studies.
Source
“Extractable leachable testing, or chemical characterization, is also usually conducted before the in vivo testing.”
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FDA registered and ISO 17025 accredited.
Source
“PBL is FDA registered and is ISO 17025 accredited.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 biocompatibility testing.
- Companies needing in vitro, in vivo, and analytical testing services.
- Firms seeking support with Biological Evaluation Plans (BEPs).
How engagement typically works
- Project-based testing services.
- Consultative approach to test planning.
Typical deliverables
- Biocompatibility test reports.
- Cytotoxicity test results.
- Extractables and Leachables data.
- Chemical characterization reports.
Good to know
- Best when requiring specialized biocompatibility and analytical testing expertise.
HQ:
Hercules, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-18
Test Types Offered:
Cytotoxicity, Hemocompatibility, Systemic toxicity, Irritation, Sensitization, Implantation
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Toxicological risk assessment is conducted on the leachable extracts for potentially harmful or toxic chemicals.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
Yes
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-5, ISO 10993-18
Test Types Offered
Biocompatibility testing, Cytotoxicity testing, Extractables and Leachables testing, Chemical characterization, In vitro testing, In vivo testing, Analytical testing, Hemolysis testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
