Chiron Corporation

Novartis Vaccines & Diagnostics, Gmbh

Novartis Ag

Other

G.d. Searle LLC

Maninder S Hora

Bao-lu Chen

Bret A Shirley

Susan Babuka

Minna Choe

Melanie Tellers

Derek T O'Hagan

Manmohan Singh

Robert F Halenbeck

Kirk William Johnson

Glenn J Dorin

Gary V Johnson

Mark E Gustafson

Hassan Madani

Gary S Bild

Sidney N Wolfe

Bo H Arve

Gregory L Pattison

Michael Tsang

Rajsharan K Rana

Jia-Hwa Fang

Qiang Ye

Nandini Katre

Mammohan Singh

John Asherman

Bret Shirley

Raisharan K Rana

Bao-Lu Chen

An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T(b) a denaturing distillation carried out at a temperature T; wherein steps (a) and (b) may be performed in either order; Tand Tare sufficient to cause squalene to boil; T&#x3e;T; and T&#x3e;200&#xb0; C.

Methods for preparing squalene

An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T; (b) a denaturing distillation carried out at a temperature T; wherein steps (a) and (b) may be performed in either order; Tand Tare sufficient to cause squalene to boil; T&#x3e;T; and T&#x3e;200&#xb0; C.

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-&#x3b2;) and methods useful in their preparation are provided. The compositions comprise the IFN-&#x3b2; solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-&#x3b2; in pharmaceutical compositions, are provided.

HSA-free formulations of interferon-Beta

HSA-free formulations of interferon-&#x3b2;

Microparticles with adsorbed complexes of macromolecule and detergent, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(&#x3b1;-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surfaces of the microparticles have adsorbed thereon a complex of biologically active macromolecules, such as nucleic acids, polypeptides, antigens, and adjuvants, and a detergent. Preferred polymers are poly(D,L-lactide-co-glycolides), more preferably those having a lactide/glycolide molar ratio ranging from 40:60 to 60:40 and having a molecular weight ranging from 30,000 Daltons to 70,000 Daltons. Preferred macromolecules are bacterial and viral antigens (such as HIV antigens, meningitis B antigens, streptococcus B antigens, and Influenza A hemagglutinin antigens) as well as polynucleotides that encode for such antigens.

Microparticle compositions and methods for the manufacture thereof

Stabilized liquid polypeptide-containing pharmaceutical compositions are provided. The compositions comprise an amino acid base, which serves as the primary stabilizing agent of the polypeptide, and an acid and/or its salt form to buffer the solution within an acceptable pH range for stability of the polypeptide. Methods for increasing stability of a polypeptide in a liquid pharmaceutical composition and for increasing storage stability of such a pharmaceutical composition are also provided.

Stabilized liquid polypeptide-containing pharmaceutical compositions

Stabilized pharmaceutical formulations comprising IFN-&#x3b2; and highly purified mannitol are provided. The highly purified mannitol stabilizes the compositions by reducing the formation of IFN-&#x3b2; adducts in comparison with IFN-&#x3b2; formulated with mannitol that has not been highly purified. Methods for increasing the stability of IFN-&#x3b2; or a variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.

Stabilized interferon compositions

HSA-free formulations of interferon-beta

A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23&#xb0; C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.

IGF-1 composition and its use

Compositions are described that are suitable for formulating TFPI. Solubilizers and stabilizers facilitate the preparation of pharmaceutically acceptable compositions of TFPI at various concentrations.

Formulation, solubilization, purification, and refolding of tissue factor pathway inhibitor

IGF-I composition and its use

Growing community of inventors

Danville, CA, United States of America

Maninder S Hora