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, with a strong focus on biocompatibility testing for medical devices. They are dedicated to ensuring product safety and regulatory compliance for their clients.
**Expertise & scope**
* Expertise in biocompatibility testing, adhering to ISO 10993 standards.
* Offers a range of services including in vitro, in vivo, and analytical testing.
* Specializes in cytotoxicity testing (MEM Elution, Agarose Overlay, Direct Contact).
* Conducts extractables and leachables testing, also known as chemical characterization.
* Provides services for medical devices, delivery devices, and combination products.
* Supports pharmaceutical and biopharmaceutical manufacturing and development.
* Offers bioanalysis for clinical trials.
**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, with a strong focus on biocompatibility testing for medical devices. They are dedicated to ensuring product safety and regulatory compliance for their clients.
**Expertise & scope**
* Expertise in biocompatibility testing, adhering to ISO 10993 standards.
* Offers a range of services including in vitro, in vivo, and analytical testing.
* Specializes in cytotoxicity testing (MEM Elution, Agarose Overlay, Direct Contact).
* Conducts extractables and leachables testing, also known as chemical characterization.
* Provides services for medical devices, delivery devices, and combination products.
* Supports pharmaceutical and biopharmaceutical manufacturing and development.
* Offers bioanalysis for clinical trials.
**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 a planning stage that involves collecting data on device materials and developing a Biological Evaluation Plan (BEP). They recommend chemical characterization and in vitro screening, such as cytotoxicity testing, before proceeding to in vivo studies. Their Biocompatibility Planning Tool (BioPT) can assist manufacturers in determining the necessary tests. The company operates under cGMP/GLP compliance and holds ISO certification, underscoring their commitment to quality systems and regulatory standards.
Key Highlights
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Specializes in biocompatibility testing for medical devices, adhering to ISO 10993 standards.
Source
“Biocompatibility Testing (ISO 10993)”
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Offers comprehensive in vitro, in vivo, and analytical services.
Source
“offering comprehensive in vitro, in vivo, and analytical services”
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Performs cytotoxicity testing using MEM Elution, Agarose Overlay, and Direct Contact methods.
Source
“There are three in vitro cytotoxicity tests that PBL performs: MEM Elution, Agarose Overlay, and Direct Contact.”
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Conducts extractable and leachable testing, crucial for chemical characterization.
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.”
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Animal science operations are accredited by AAALAC.
Source
“Our animal science operations are accredited by AAALAC.”
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.
- Pharmaceutical and biopharmaceutical companies seeking manufacturing and development support.
How engagement typically works
- Collaborative planning and testing process.
- Focus on regulatory compliance and product safety.
- Support for various stages of product development.
Typical deliverables
- Biocompatibility testing reports.
- Cytotoxicity test results.
- Extractables and leachables data.
- Analytical chemistry reports.
- In vivo study data.
Good to know
- Best when clients have a clear understanding of their device materials and intended use.
- Requires a well-defined Biological Evaluation Plan (BEP).
HQ:
Hercules, US
Languages:
English
Timezones:
America/Los_Angeles
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States
Industries:
Medical Devices
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:
No
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, In vitro testing, In vivo testing, Analytical testing, Bioanalysis
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
