FEASIBILITY OF PRECLINICAL SCALEUP OF LIPOSOMAL TNF

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$48,158.00
Award Year:
1992
Program:
SBIR
Phase:
Phase I
Contract:
n/a
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
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Alan C Hayman
(713) 367-1666
Business Contact:
() -
Research Institution:
n/a
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.

* information listed above is at the time of submission.

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