Shire Viropharma Incorporated

Kiniksa Pharmaceuticals, Ltd.

Levo Therapeutics, Inc.

Viropharma Biologics LLC

Colorado State University Research Foundation

Coherus Biosciences, Inc.

Ryan Erik Holcomb

Mark Cornell Manning

Stephen Ruddy

Zahra Shahrokh

Christopher Bryant

Dave Nichols

Phillip M Levesque

Kenneth F Reardon

David S Dandy

Sara Cotter

Derrick Spencer Katayama

Philip M Levesque

Joseph William Cormier

Compositions and methods for the treatment and/or prevention of disorders associated with C1 esterase inhibitor deficiency are disclosed.

C1-INH compositions and methods for the prevention and treatment of disorders associated with C1 esterase inhibitor deficiency

The present disclosure includes a method of making an improved carbetocin drug product. The disclosed method for making an improved carbetocin drug product comprises agitating a carbetocin preparation containing an aqueous solution of carbetocin and one or more excipients for a period of time to initiate the formation of aggregate-forming solids and filtering off the aggregates that form before further processing the remaining carbetocin into a final drug product. The present disclosure also relates to an improved carbetocin drug product, wherein the drug product is substantially free of aggregate-forming solids. The disclosed carbetocin drug product can be used for the treatment of a neurodevelopmental disorder, such as Prader-Willi syndrome. Additionally, the disclosed carbetocin drug product shows content uniformity of carbetocin over long periods of time before and after one or more freeze/thaw cycles, provides enhanced convenience and patient compliance, and/or are highly concentrated.

Carbetocin drug product and process for preparing same

The present invention relates to aqueous pharmaceutical compositions comprising a high concentration (i.e., greater than 50 milligrams per milliliter) of adalimumab (including antibody proteins considered or intended as 'biosimilar' or 'bio-better' variants of commercially available adalimumab) suitable for long-term storage, and methods of manufacture of the compositions; methods of their administration; and articles containing the same.

High concentration formulations of adalimumab

The present disclosure includes a method of making an improved carbetocin drug product. The disclosed method for making an improved carbetocin drug product comprises agitating a carbetocin preparation containing an aqueous solution of carbetocin and one or more excipients for a period of time to initiate the formation of aggregate-forming solids and filtering off the aggregates that form before further processing the remaining carbetocin into a final drug product. The present disclosure also relates to an improved carbetocin drug product, wherein the drug product is substantially free of aggregate-forming solids. The disclosed carbetocin drug product can be used for the treatment of a neurodevelopmental disorder, such as Pr&#xe4;der-Willi syndrome. Additionally, the disclosed carbetocin drug product shows content uniformity of carbetocin over long periods of time before and after one or more freeze/thaw cycles, provides enhanced convenience and patient compliance, and/or are highly concentrated.

Agitation process for preparing a carbetocin drug product

The present invention provides, among other things, stable formulations comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation.

Stable anti-OSMR antibody formulation

The application describes stable aqueous compositions comprising relatively high concentrations of carbetocin and a solubilizer and/or surface active agent. The disclosed carbetocin compositions are effective in the treatment of a neurodevelopmental disorder, such as Pr&#xe4;der-Willi syndrome. Additionally, the disclosed carbetocin compositions show improved stability at room temperature and/or under accelerated conditions of stress.

Methods of treating prader-willi syndrome with carbetocin

Herein disclosed are biosensing systems that measure lactose concentration in a solution.

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Fort Collins, CO, United States of America

Ryan Erik Holcomb