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. They focus on ensuring product safety and regulatory compliance.
**Expertise & scope**
* Biocompatibility testing services aligned with ISO 10993 standards.
* In vitro testing, including cytotoxicity (MEM Elution, Agarose Overlay, Direct Contact).
* In vivo biocompatibility testing.
* Extractables and leachables testing (chemical characterization) per ISO 10993-18.
* Hemolysis testing according to ASTM F756.
* Support for medical device, delivery device, and combination product services.
* Analytical, bioanalytical, and microbiology testing services.
* Pharm/Biopharm manufacturing and drug development support, including 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. They focus on ensuring product safety and regulatory compliance.
**Expertise & scope**
* Biocompatibility testing services aligned with ISO 10993 standards.
* In vitro testing, including cytotoxicity (MEM Elution, Agarose Overlay, Direct Contact).
* In vivo biocompatibility testing.
* Extractables and leachables testing (chemical characterization) per ISO 10993-18.
* Hemolysis testing according to ASTM F756.
* Support for medical device, delivery device, and combination product services.
* Analytical, bioanalytical, and microbiology testing services.
* Pharm/Biopharm manufacturing and drug development support, including 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 device materials, manufacturing, and sterilization processes. They recommend developing a Biological Evaluation Plan (BEP) to determine necessary tests, often starting with chemical characterization and in vitro screening before proceeding to in vivo studies. Their Biocompatibility Planning Tool (BioPT) can assist manufacturers in this process. The company operates under cGMP/GLP compliance and holds ISO certification, underscoring their commitment to quality systems and regulatory adherence.
Key Highlights
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Specializes in biocompatibility testing for medical devices, including in vitro, in vivo, and analytical services.
Source
“Pacific BioLabs is a leading CRO specializing in biocompatibility testing for medical devices, offering comprehensive in vitro, in vivo, and analytical services”
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Offers specific in vitro cytotoxicity tests such as MEM Elution, Agarose Overlay, and Direct Contact.
Source
“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, crucial for chemical characterization under ISO 10993-18.
Source
“Device Extractables and Leachables – ISO 10993-18”
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Conducts hemolysis testing in accordance with ASTM F756.
Source
“Hemolysis Testing – ASTM F756”
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Is 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.
- Pharmaceutical and biopharmaceutical companies seeking manufacturing and development support.
How engagement typically works
- Project-based testing.
- Consultative planning for testing strategies.
- Support for regulatory submissions.
Typical deliverables
- Biocompatibility testing reports.
- Cytotoxicity test results.
- Extractables and leachables data.
- Analytical chemistry reports.
- Stability testing data.
Good to know
- Best when requiring services compliant with ISO 10993 and other relevant standards.
- Best when needing a CRO with FDA registration and ISO accreditation.
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, Hemolysis testing, In vitro testing, In vivo testing, Analytical chemistry, Bioanalysis, Microbiology 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
