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, crucial for chemical characterization.
* Analytical chemistry services, including ICP-MS trace elemental analysis.
* Support for medical device, delivery device, and combination product development.
* Services also extend to pharmaceutical and biopharmaceutical manufacturing and development support.

**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 gathering data on device materials and developing a Biological Evaluation Plan (BEP) to determine necessary tests. They offer a Biocompatibility Planning Tool (BioPT) to assist manufacturers. Testing typically progresses from in vitro screening, such as cytotoxicity, followed by extractables and leachables analysis, and then in vivo testing. Their services are designed to support manufacturers in meeting regulatory requirements and ensuring patient safety.

Key Highlights

  • Specializes in biocompatibility testing for medical devices, adhering 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...”
  • Offers a range of in vitro tests, including cytotoxicity (MEM Elution, Agarose Overlay, Direct Contact). Source
    “There are three in vitro cytotoxicity tests that PBL performs: MEM Elution, Agarose Overlay, and Direct Contact.”
  • Performs in vivo biocompatibility testing and extractables/leachables analysis (ISO 10993-18). Source
    “In vivo Biocompatibility Testing; Device Extractables and Leachables – ISO 10993-18”
  • FDA registered and ISO 17025 accredited. Source
    “PBL is FDA registered and is ISO 17025 accredited.”
  • Provides analytical and bioanalytical chemistry services, including ICP-MS trace elemental analysis. Source
    “ICP-MS Trace Elemental Analysis”

Certifications & Trust Signals

  • FDA registered. Source
    “PBL is FDA registered and is ISO 17025 accredited.”
  • ISO 17025 accredited. Source
    “PBL is FDA registered and is ISO 17025 accredited.”
  • Animal science operations accredited by AAALAC. Source
    “Our animal science operations are accredited by AAALAC.”

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 development and manufacturing support.
How engagement typically works
  • Project-based testing.
  • Consultative approach to planning and evaluation.
Typical deliverables
  • Biocompatibility testing reports.
  • Cytotoxicity test results.
  • Extractables and leachables data.
  • Analytical chemistry reports.
  • Biological evaluation plans.
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, In vitro testing, In vivo testing, Analytical chemistry, ICP-MS trace elemental analysis
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
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