MARYLAND HEIGHTS, MO / Lee Biosolutions is proud to announce that it has an exclusive Clinical Trail Supply Agreement with St. Teresa Medical, Inc. to support their SURGICLOT(R) Haemostatic Dressing. Lee Biosolutions' scientific team's extensive expertise with coagulation factors such as Human Thrombin and Fibrinogen made it an ideal partner to meet Saint Teresa Medical's requirements. St. Teresa Medical is a medical device company commercializing a new haemostatic technology platform.
Lee Biosolutions partnership with St. Teresa Medical ,covers the process development and manufacture of bulk cGMP Human Fibrinogen and Thrombin, analytical support and testing services, analytical methods development and validation, stability testing and viral clearance management. St. Teresa Medical owns the analytical methods and validation processes as a result of our close collaboration.
Burton Lee, CEO "St. Teresa Medical is an innovator in the market place and we are very proud that they chose Lee Biosolutions as a key supplier for this novel (or cutting edge) technology."
About Lee Biosolutions, Inc.:
We are headquartered in a 41,000 square feet state of the art cGMP-compliant facility in Maryland Heights, MO. Lee Biosolutions is a certified, licensed ISO, FDA, EPA and USDA leader in process development and bulk manufacturing of high quality purified enzymes and related proteins for research and clinical diagnostic tests. Lee Biosolutions products are used for such pathologies as cardiac disease, cancer, diabetes, urine analysis, coagulation, obesity, inflammatory, neurological, autoimmune diseases and immunological disorders
Lee Biosolutions’ facility is registered with the FDA. These products are produced in accordance with the FDA’s “Guidance for Industry: cGMP for Phase 1 Investigational Drugs” and Q7A, Section 19: “APIs for Use in Clinical Trials”.
Lee Biosolutions, Inc
