Accession Number:

ADA455424

Title:

Develop Systems for Manufacturing 100,000,000 Doses of an Emergency Pharmaceutical (e.g. Vaccine or Monoclonal Antibody) Within 2 Months of Product Identification

Descriptive Note:

Final rept. 15 Aug 2005-31 Mar 2006

Corporate Author:

GENENCOR INTERNATIONAL PALO ALTO CA

Report Date:

2006-06-08

Pagination or Media Count:

22.0

Abstract:

Based on the data we have generated in the first six months of the project, we believe we have exceeded the milestones for this project. Initial genetic constructs for the Herceptin IgG human antibody were made and transformed into Trichoderma reesei. These strains were screened for antibody production in shake flasks. A few of the strains were tested at the 14-liter fermentation scale. We have been able to produce over 3 gL of full length IgG as determined by ELISA. We have produced 0.7 gL of a non-glycosylated variant of the Herceptin IgG human antibody at 14L scale. A number of different genetic constructs have also been made to optimize the Kex2 cleavage site. Our best constructs show greater than 90 cleavage of the fusion proteins to products. Our data indicate that Trichoderma reesei is an efficient host for the production of antibodies.

Subject Categories:

  • Organic Chemistry
  • Biochemistry

Distribution Statement:

APPROVED FOR PUBLIC RELEASE