Research Progress Report Submitted to the U.S. Naval Medical R & D command
Abstract
Since September 1989 Cryopharm has focused on two primary goals: (1) conduct of the first clinical test of lyophilized reconstituted human red cells in normal volunteers, and (2) continued basic research to characterize and improve the yield and quality of reconstituted red cells. As detailed in this progress report, Cryopharm has met a series of milestones (detailed in the Milestones Chart submitted in our September 1989 proposal and duplicated as Appendix II of this report) designed to position the company to begin human testing of autologous lyophilized red cells. These milestones include definition of a working shelf lyophilization cycle to implement for the first human test samples, construction of a Class 100 clean room facility, validation of sterile processing, and development of a working prototype lyophilization container. Preliminary studies of the residual moisture and shelf life of lyophilized human red cells have also been conducted. We believe that significant progress has been attained towards out proposed Year 1 milestones. In Appendix I of this report we include a photographic description of the current Cryopharm lyophilization and reconstitution process, to illustrate the blood container, Class 100 facility, and the current reconstitution/wash procedure. Our basic research continues to focus on improved techniques to streamline the entire process.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 30, 1990
- Accession Number
- ADA227216