Collaboration is key to building new concepts and improving upon existing ones.
Consulting
Collaboration is key to building new concepts and improving upon existing ones.
Testing
Offering ISO and customized test procedures for blood compatibility.
Below is an example of how Lupine Medical partners with device manufacturers of products ranging from short-term skin-contacting devices to permanent, bloodstream contacting implants.
- Provide supporting materials and rationales for the fluid exchange model of drug dissolution for in-vitro elution and antimicrobial efficacy models
- Research applicable microbes that lead to the most infections for varying implanted devices
- Design in-vitro test plans around these microbes
- Determine minimum inhibitory concentration (MIC) of drug against these microbes
- Establish minimum bactericidal concentration (MBC) of drug against bacteria
- Oversee test method development, implementation, validation execution and reporting
- Demonstrate correlation between drug release and in-vitro antimicrobial efficacy
- Summarize reports and present data to FDA
- Execute in-vitro assay for the detection of activated platelets after device exposure
- Use flow-cytometry methods to identify blood markers for activation
- Identify and quantify platelets adhered to device surface using confocal microscopy
- Develop and validate customized blood compatibility testing