21st Century Medicine --Expanding the Boundaries of Preservation Science

Contract Research Services

From project design to commercial deployment, we provide research services for custom-made biochemical solutions, protocols and devices used for cryogenic preservation of living tissues. Whether you need complete comprehensive services or specific research tasks, we take great care to deliver results that you can count on.

Our bio-vitrification platform technology is designed to provide new preservation options for corneas, venous grafts, skin grafts, cartilage, human ova, and other precious & delicate tissues while proprietary research continues toward organ vitrification and the creation of true organ banking.

The benefits of our research are not limited to health care. Advances in low temperature biophysics and our ability to control the formation of ice through a wide range of temperatures could find bio-logistical application in agriculture, food processing, and other major industries.

To discuss solutions for your preservation challenges, please contact us toll-free at 866-889-1215.

Custom Research

To best serve your needs, our team of project and technical managers will develop upfront statements of work and timetables to ensure that you receive exactly what you need:

Our research services include:

  • Research of clinical and regulatory requirements
  • Raw material supplier assessment
  • Experimental design for testing candidate solution formulations
  • Experimental design for proper addition and removal protocols
  • Experimental design for proper cooling and warming curves
  • Experimentation and design of specific preservation system
  • Compilation and interpretation of experimental results
  • Construction of complete specifications for preservation systems
  • Determination of shipment classifications and specifications
  • FDA registration of final product solution formulations
  • Written process description for manufacture, including: control plan, FMEA, procedures, specifications, and process capability assessment

Process and Device Research

We use Quality Function and Deployment (QFD) design processes to match performance, regulatory and user requirements as closely as possible to the final engineering design. We liaise with our engineering partners to construct any initial manufacturing specifications and initial Failure Mode and Effects Analysis (FMEA). Our engineering team also assesses potential component and material suppliers in an effort to streamline manufacturing and control process costs.

Our final reports include the results of all research findings, recommendations, and estimation of costs to move deliverable technologies relating to manufacture toward commercial applications.

Our manufacturing assessment and process design services include the following:

  • Drafting of component and/or raw material specifications.
  • Supplier assessment.
  • Determination of process inventory requirements
  • Failure mode testing and estimations
  • Drafting of user instructions
  • Warranty assessment
  • Written Process Description for manufacture, including: control plan, FMEA, procedures, specifications, and process capability assessment
  • Manufacture of prototype(s)

To discuss solutions for your process and device research needs, please contact us toll-free at 866-889-1215.