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Hemosol starts producing blood substitute.

Initial production of "HemOlinK (TM)", Hemosol's first blood substitute product, is now underway at the company's plant in Etobicoke, ON.

Hemosol's president and chief executive officer, Alun Davies, said production commenced following the completion of the first stage of expansion of its facilities which includes additional containment and clean rooms, increased production areas and the installation of equipment and utilities for higher volume production.

"We've moved on schedule from the pilot plant to the production stage for a relatively modest investment," he said. "We are now in a position to supply a highly characterized product in the volumes required while meeting GMP (Good Manufacturing Practices) standards for the balance of our preclinical testing as well as Phase I and Phase II clinical trials. This is one of a number of important milestones and gives us confidence in the quality and direction of our research and development program," he said.

Total cost of the original pilot plant and the initial first stage production facilities is approximately $7 million.

Hemosol expects to file an Investigational New Drug application with the U.S. Food and Drug Administration and a Preclinical New Drug Submission with the Health Protection Branch, Health and Welfare Canada late this year. Based on these applications, Hemosol intends to commence human trials early next year with market introduction targeted for 1996.

The company's proprietary and licensed technologies involve the separation of hemoglobin from red blood cells and the controlled chemical modification of the purified hemoglobin using a process called "cross-linking". The latter process modifies the oxygen-binding and delivery properties of hemoglobin to those similar to whole red blood cells.

Hemosol's cross-linked product has significant advantages. It is universally compatible, can be stored for long periods of time and is free of contamination by blood-borne diseases such as the HIV virus or hepatitis. A safe, effective blood substitute would be used in a wide range of medical and surgical applications.

The company is currently developing two cross-linking technologies. The first one uses a derivative of raffinose, a complex sugar molecule, to produce HemOlinK (TM) (oR poly-Hb), a stable and efficient transporter of oxygen and the company's first product to be produced in quantity for clinical trials. The second cross-linker employs a newly-developed reagent based on the acyl phosphate ester of trimesic acid and offers the prospect of developing custom-designed products for a variety of applications based on differing product characteristics.
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Title Annotation:Hemosol Inc.
Publication:Canadian Chemical News
Date:Jul 1, 1993
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