Biocompatibility Assessment Services
At Materials Metric, we provide comprehensive biocompatibility assessment services to evaluate the safety and compatibility of materials intended for medical, pharmaceutical, and biomedical applications. These tests ensure that materials do not cause harmful biological reactions when in contact with living tissues, making them crucial for medical devices, implants, and drug formulations.
In-vitro Cell-Based Assays
In-vitro cell-based assays are laboratory tests that analyze how materials interact with living cells in a controlled environment. These tests help assess cytotoxicity, cell viability, and biological responses before in-vivo studies.
Capabilities:
Cell viability and proliferation studies
Assessment of material-induced inflammation or apoptosis
Functional assays for biomaterial performance
In-vivo Studies
In-vivo studies involve testing materials or medical devices in live animal models to assess their safety, functionality, and long-term biological effects. These tests provide critical insights into systemic toxicity, immune response, and tissue integration.
Capabilities:
Biodegradation and bioresorption analysis
Tissue response and inflammation evaluation
Long-term performance assessment under physiological conditions
Cytotoxicity and Systemic Toxicity Testing
Assessing toxic effects of materials on biological systems
Capabilities:
Evaluates whether a material damages or kills cells
Uses standard assays like MTT, LDH, and Trypan Blue exclusion
Essential for compliance with ISO 10993-5 for medical device testing
Extractables and Leachables (E&L) Testing
Ensuring materials do not release harmful substances
Extractables and Leachables (E&L) testing identifies potentially hazardous chemicals that may be released from materials under different conditions, ensuring product safety.
Capabilities:
Identification of organic and inorganic extractables using GC-MS, LC-MS, and ICP-MS
Simulated-use conditions to detect leachable contaminants
Compliance with USP <1663> and <1664>, ISO 10993-18, and FDA guidelines
