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FEASIBILITY OF PRECLINICAL SCALEUP OF LIPOSOMAL TNF

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
19071
Program Year/Program:
1992 / SBIR
Agency Tracking Number:
19071
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Argus Pharmaceuticals Inc
3400 Research Forest Drive The Woodlands, TX 77381
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 1992
Title: FEASIBILITY OF PRECLINICAL SCALEUP OF LIPOSOMAL TNF
Agency: HHS
Contract: N/A
Award Amount: $48,158.00
 

Abstract:

IN THIS PHASE I EFFORT, WE WILL DEMONSTRATE THE ABILITY TO SCALE UP THE PRODUCTION OF A LEAD LIPOSOMAL FORMULATION CANDIDATE OF ACYLATED, LIPOPHILIC RHUTNF. WE WILL SUBJECT THE BACTERIAL RECOMBINANT PROTEIN TO ACYLATION WITH THE N-HYDROXYSUCCUNIMIDE ESTER OF CAPRYLIC ACID (C3) TO ACHIEVE LIMITED SUBSTITUTION (1.5 TO 2 RESIDUES PER TNF TRIMER). THE IDENTITY AND EXTENT OF SUBSTITUTION OF THE TARGET AMINO GROUPS IN TNF WILL BE ESTABLISHED BY A TRYPTIC DIGESTION/MASS SPECTROSCOPY STRATEGY. AN OPTIMAL SUV FORMULATION COMPOSED OF DPPC, DSPC, AND DSPE-PEG WILL BE DEFINED BASED ON HIGH BINDING TO ACYLATED TNF, HIGH PHASE- TRANSITION TERPERATURE, AND STABILITY TO STORAGE UNDER MOCK PSYSIOLOGICAL CONDITIONS. WHEN OPTIMAL CONDITIONS FOR TNF ACYLATION AND COMPOSITION OF SUVS HAVE BEEN DETERMINED, FINAL FORMULATION OF LIPOSOMAL LIPOPHILIC TNF WILL BE CONDUCTED AT A SCALE (>20 MG TNF/1 GM LIPID) APPROPRIATE FOR FUTURE PRECLINICAL EVALUATION. THIS FEASIBILITY STUDY SHOULD FACILITATE COMPLIANCE WITH QUALITY CONTROL MEASURES LIKELY TO BE REQUESTED BY THE FDA IN FUTURE PRE-IND DISCUSSIONS.

Principal Investigator:

Alan C Hayman
7133671666

Business Contact:

Small Business Information at Submission:

Argus Pharmaceuticals Inc
3400 Research Forest Drive The Woodlands, TX 77381

EIN/Tax ID:
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No