Boehringer Ingelheim Pharma Gmbh & Co Kg

Boehringer Ingelheim International Gmbh

Torsten Schultz-Fademrecht

Patrick Garidel

Karoline Bechtold-Peters

Wolfgang Friess

Stefan Bassarab

Richard Fuhrherr

Steven John Padula

Annette Bettina Galler

Beate Fischer

Elaine Ee-Ling Wang

Sven Bahrenburg

Andrea Eiperle

William Troy Loging

Gerald Henry Nabozny

Thomas Hennes

It is disclosed an improved multi-step process for the preparation of a highly concentrated liquid formulation containing biomolecules comprising the steps of (a) a first ultrafiltration UF1; (b) a first diafiltration DF1; (c) a second diafiltration DF2; and (d) a second ultrafiltration UF2; wherein an aqueous solution of one or more salts, as liquid medium B, is used for step (b) and water or an aqueous solution of one or more salts, as liquid medium C, is used for step (c), wherein the one or more salts used for step (b) are the same or different from the one or more salts used for step (c) and wherein the liquid medium B has an ionic strength which is higher than the ionic strength of the liquid medium C. The process according to the present invention allows the preparation of well-defined highly concentrated formulations containing biomolecules, particularly proteins, intended for pharmaceutical or non-pharmaceutical use. Unwanted excipient(s) of the starting liquid biomolecule formulation, may be reduced under solution conditions, to very low levels or levels lower than the detection limit.

Process for the preparation of concentrated liquid formulations containing biomolecules

The present invention relates to anti-IL-23p19 binding compounds, in particular new humanized anti-IL-23p19 antibodies, pharmaceutical compositions and therapeutic and diagnostic methods and compositions for using the same.

Anti-IL-23 antibodies

The invention concerns the field of biomolecule formulation screening and stability testing. It concerns a method for the evaluation of the colloidal stability of liquid biopolymer solutions. The present invention describes a method for determining the stability of a liquid pharmaceutical composition comprising: a) providing a liquid pharmaceutical composition in a container, b) shaking said container on a shaker, whereby the shaker performs an oloid movement, c) determining the stability of said liquid pharmaceutical composition.

Method for the evaluation of the colloidal stability of liquid biopolymer solutions

The invention therefore relates to protein-containing powders, wherein the proportion of phenylalanine is at least 30% (w/w), or at least 40% (w/w). It has been shown that phenylalanine-containing powders, particularly after spray drying, are very suitable in terms of their aerodynamic characteristics and protein stabilization for preparing powders or protein compositions with improved aerodynamic properties. The main component is phenylalanine and the optional further component is an excipient which has good water-solubility compared with phenylalanine, preferably a sugar or a polyol.

Inhalable powders comprising protein, phenylalanine, and other protein stabilizers

The present invention concerns powders containing a pharmaceutical active substance and a combination of excipients comprising at least one 1,4 O-linked saccharose derivative selected from the compounds: 1,4 O-linked D-Gal-saccharose (lactosucrose), 1,4 O-linked D-Glu-saccharose (glucosyl sucrose), or 1,4 O-linked Glu-Glu-saccharose (maltosyl sucrose) in combination with at least one further excipient. The other excipient is preferably an amino acid, a peptide and/or a mono-, di- and/or oligosaccharide, wherein the oligosaccharide may be a second 1,4 O-linked saccharose derivative, provided that this is different from the first.

Powder comprising new compositions of oligosaccharides and methods for their preparation

The present invention relates to a spray-dried powder and method for its manufacture. A spray dried powder containing a pharmaceutical active substance and one or more 1,4 O-linked saccharose derivatives chosen from the compounds: 1,4 O-linked D-gal-saccharose (lactosucrose), 1,4 O-linked D-glu-saccharose (glucosyl sucrose) or 1,4 O-linked glu-glu-saccharose (maltosyl sucrose). Preferred combinations are such that they contain glucosyl and maltosyl sucrose.

Spray-dried powder comprising at least one 1,4 O-linked saccharose-derivative and methods for their preparation

Disclosed are applications of oligosaccharides/oligosaccharide mixtures for the production and stabilization of pharmaceutical compositions, chiefly powders, that contain antibodies or antibody derivatives as pharmaceutical active substance. The production of powders is accomplished through spray drying or freeze drying. Also disclosed are the corresponding antibody-containing powders as well as processes for their production.

Growing community of inventors

Biberach, Germany

Torsten Schultz-Fademrecht