Artes Medical Jun 2004 - Nov 2008
Vice-President, Manufacturing Operations
Anosys 2000 - 2004
Manufacturing Director
Cohesion Technologies Nov 1997 - Mar 2000
Senior Process Engineer
Biowerks Oct 1996 - Dec 1997
Principal
Collagen Corporation Nov 1990 - Nov 1996
Clinical Formulations Manager
Education:
Arizona State University 1995 - 1995
Cal State East Bay - College of Business & Economics 1979 - 1984
Bachelors, Bachelor of Science, Biochemistry
American High School 1975 - 1979
Skills:
Fda Gmp Biotechnology Medical Devices Manufacturing Pharmaceutical Industry Validation Technology Transfer V&V Biopharmaceuticals Aseptic Processing Quality System Life Sciences Contract Manufacturing Capa Regulatory Affairs Sop Vaccines Iso 13485 Laboratory Pharmaceutics Iso Change Control Computer System Validation Purification Lifesciences Product Development R&D Quality Assurance Commercialization Analytical Chemistry Glp Clinical Trials Start Ups Formulation Design Control 21 Cfr Part 11 Product Launch Regulatory Requirements U.s. Food and Drug Administration Standard Operating Procedure Calibration Gxp Good Laboratory Practice Strategy
Woonza M. Rhee - Palo Alto CA Richard A. Berg - Los Altos CA Joel S. Rosenblatt - Palo Alto CA Jacqueline A. Tefft - Redwood City CA Larry J. Braga - Fremont CA Thomas L. Smestad - Palo Alto CA
Assignee:
Collagen Corporation - Palo Alto CA
International Classification:
C08G 6349 C08G 6391
US Classification:
525 541
Abstract:
The present invention discloses a novel method for preparing crosslinked biomaterial compositions for use in the augmentation of soft or hard tissue. In general, the method comprises mixing a biocompatible polymer, which is preferably collagen, with a sterile, dry crosslinking agent, which is preferably a synthetic hydrophilic polymer such as a functionally activated polyethylene glycol. Also provided are preferred processes for preparing sterile, dry crosslinking agents contained within syringes for use in the method of the invention. Methods for sterilization of the crosslinking agent include, but are not limited to, sterile filtration, aseptic processing, and e-beam or gamma irradiation. Methods for providing augmentation of soft or hard tissue using crosslinked biomaterial compositions prepared according to the method of the invention are also disclosed.
Process For Preparing A Sterile, Dry Crosslinking Agent
Woonza M. Rhee - Palo Alto CA Richard A. Berg - Los Altos CA Joel S. Rosenblatt - Palo Alto CA Jacqueline A. Schroeder - Redwood City CA Larry J. Braga - Fremont CA Thomas L. Smestad - Palo Alto CA Abigail Freeman - Fremont CA
Assignee:
Collagen Corporation - Palo Alto CA
International Classification:
B01J 1908 A01N 102 A61F 200
US Classification:
210748
Abstract:
The present invention discloses a novel method for preparing crosslinked biomaterial compositions for use in the augmentation of soft or hard tissue. In general, the method comprises mixing a biocompatible polymer, which is preferably collagen, with a sterile, dry crosslinking agent, which is preferably a synthetic hydrophilic polymer such as a functionally activated polyethylene glycol. Also provided are preferred processes for preparing sterile, dry crosslinking agents contained within syringes for use in the method of the invention. Methods for sterilization of the crosslinking agent include, but are not limited to, sterile filtration, aseptic processing, and e-beam or gamma irradiation. Methods for providing augmentation of soft or hard tissue using crosslinked biomaterial compositions prepared according to the method of the invention are also disclosed.
Method Of Preparing Crosslinked Biomaterial Compositions For Use In Tissue Augmentation
Woonza M. Rhee - Palo Alto CA Richard A. Berg - Los Altos CA Joel S. Rosenblatt - Palo Alto CA Jacqueline A. Tefft - Redwood City CA Larry J. Braga - Fremont CA Thomas L. Smestad - Palo Alto CA
Assignee:
Collagen Corporation - Palo Alto CA
International Classification:
C08G 6348 C08G 6391
US Classification:
525 541
Abstract:
The present invention discloses a novel method for preparing crosslinked biomaterial compositions for use in the augmentation of soft or hard tissue. In general, the method comprises mixing a biocompatible polymer, which is preferably collagen, with a sterile, dry crosslinking agent, which is preferably a synthetic hydrophilic polymer such as a functionally activated polyethylene glycol. Also provided are preferred processes for preparing sterile, dry crosslinking agents contained within syringes for use in the method of the invention. Methods for sterilization of the crosslinking agent include, but are not limited to, sterile filtration, aseptic processing, and e-beam or gamma irradiation. Methods for providing augmentation of soft or hard tissue using crosslinked biomaterial compositions prepared according to the method of the invention am also disclosed.
Larry Braga (1973-1975), Jodi Scruggs (1980-1982), Kelley Carlisle (1972-1974), Kim Martin (1972-1974), Khatera Kohistani (1996-1998), Luis Velasco (1969-1971)