SBIR-STTR Award

Membrane immunoaffinity purification of factor VIII:C
Profile last edited on: 3/1/02

Program
SBIR
Agency
NIH | NHLBI
Total Award Amount
$350,000
Award Phase
2
Principal Investigator
Stephen E Zale
Activity Indicator

Company Information

Sunovion Pharmaceuticals Inc (AKA:Sepracor Inc)

84 Waterford Drive
Marlborough, MA 01752
   (508) 481-6700
   info@sepracor.com
   www.sepracor.com
Multiple Locations:   
Congressional District:   03
County:   Middlesex

Phase I

Phase I year
1988
Phase I Amount
$50,000
Hemophilia A is an inherited bleeding disorder that stems from lack of coagulation factor VIII: C (F.VIII:C). Crude preparations of plasma-derived factor VIII used in treatment of hemophilia are in short supply worldwide and carry the risk of viral disease transmission. Although ultrapurified F.VIII:C can be prepared in small quantities using immunoaffinity column chromatography, conventional affinity separations technology is not suited to large scale production of purified F.VIII:C.The objective of the proposed research is to develop a membrane- based affinity process for purification of F.VIII:C directly from blood plasma that employs methodologies established for the column-based procedure. In contrast to conventional technologies, we expect that membrane affinity processes will be amenable to industrial operations. In Phase I, a knowledge base will be established that will permit the rational design of hollow fiber membrane modules for immunoaffinity purification of F.VIII:C. In Phase II, prototype affinity modules will be constructed and purified F.VIII:C will be tested for safety and efficacy in animals.The purpose of this project is to establish the technical basis for membrane-mediated affinity purification of F.VIII:C, to develop a general approach to industrial affinity separations, and to improve the quality of life of individuals currently undergoing factor VIII replacement therapy.National Heart, Lung and Blood Institute (NHLBI)

Phase II

Phase II year
1990 (last award $$: 1990)
Phase II Amount
$300,000
Hemophilia A is an inherited bleeding disorder that stems from lack of coagulation factor VIII (F.VIII). Crude preparations of plasma-derived F.VIII used in treatment of hemophilia are in short supply worldwide and carry the risk of viral disease transmission. Although ultrapurified F.VIII can be prepared using immunoaffinity column chromatography, conventional affinity separation technology is poorly suited to large-scale production of purified F.VIII.The objective of this research is to develop a membrane-based affinity process for the purification of F.VIII directly from blood plasma. The membrane affinity processes will offer high specificity and yield, and yet be amenable to industrial operations.In Phase I, the technical feasibility of membrane immunoaffinity purification of F. VIII from plasma was established.In Phase II, the F.VIII purification process will be optimized and scaled up for production of materials for preclinical studies. F.VIII thus purified will be extensively characterized and tested for safety in animals. The purpose of this project is to establish the technical basis for membrane-mediated affinity purification of F.VIII, to develop a general approach to industrial affinity separations, and to improve the quality of life of individuals undergoing F.VIII replacement therapy.Awardee's statement of the potential commercial applications ofthe esearch: This research may lead to development of(1) a safer, more readily available, and less expensive F.VIII product that could address the needs of individuals undergoing replacement therapy, and(2) a general approach to industrial purification of therapeutic products derived from either blood plasma, fermentation media, or cell culture broths.National Heart, Lung, and Blood Institute (NHLBI)