Leukocare Ag

Kristina Kemter

Martin Scholz

Jens Altrichter

Hartwig Steckel

Regina Scherliess

Thomas Kriehuber

The present invention relates to a method for preparing viral vector-based compositions wherein the viral vector-based particles present in the composition have a particle size distribution with a polydispersity index (PDI) of less than 0.5, the method comprising the steps: (a) providing replication-deficient viral vectors; (b) providing a solution comprising at least one sugar and at least three different excipients selected from hydrophilic and amphiphilic excipients, wherein the excipients are characterized by polar, aliphatic, aromatic, negatively charged, and/or positively charged functional groups, and wherein the solution is further characterized by an excipient-sugar ratio of at least 1:2 (w/w); and (c) mixing the replication deficient viral vectors of step (a) with the solution of step (b). The present invention further relates to a viral vector-based composition obtainable by the method of the invention as well as to the viral vector-based composition of the invention for use as a prime-boost vaccine.

Method for obtaining efficient viral vector-based compositions for vaccination or gene therapy

The present invention relates to a method of producing low viscous and highly concentrated biopharmaceutical drug products comprising a biomolecule of interest, the method comprising: (a) a first phase of preparing a drug substance of the biomolecule of interest, said first phase comprising at least one processing step selected from (a1) harvesting, (a2) purification, (a3) re-buffering, and (a4) enrichment, wherein said at least one processing step in this first phase is carried out in the presence of a composition comprising at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function, and (b) a second phase of further processing the drug substance prepared in (a) to obtain a low viscous and highly concentrated biopharmaceutical drug product, said second phase comprising at least one processing step selected from (b1) re-buffering, (b2) freezing, (b3) thawing, and (b4) filling; wherein said at least one processing step in this second phase is carried out in the presence of a composition comprising (i) at least three amino acids, wherein the combination of said at least three amino acids provides at least one positively charged functional group, at least one anti-oxidative functional group, at least one osmolytic function, and at least one buffering function; and (ii) one or more sugar(s); in an amino acid:sugar ratio between 10:1 to 1:100 (w/w). The present invention further relates to a low viscous and highly concentrated biopharmaceutical drug product obtained or obtainable by the method of the invention.

Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation

The present invention relates to a method for stabilising viruses or bacteria, the method comprising embedding the viruses or bacteria in an aqueous solution, wherein the solution comprises: (i) at least three different amino acids; or (ii) at least one dipeptide or tripeptide and wherein the solution is free or substantially free of sugar(s), silanes and protein(s).

Stabilisation method for viruses or bacteria

The present invention relates to a method for producing stabilised vaccines, the method comprising: (a) mixing antigens with a solution comprising: (i) chitosan; (ii) at least three different amino acids and/or at least one dipeptide or tripeptide; and (iii) a sugar; and (b) drying the mixture obtained in (a).

Method for the production of stabile vaccines

The present invention relates to a method for preventing the unfolding of a (poly)peptide during drying and/or inducing the (re-)folding of a (poly)peptide after drying, comprising the step of embedding the (poly)peptide in an aqueous solution, wherein the solution comprises (i) at least three different amino acids; or (ii) at least one dipeptide or tripeptide; and wherein the solution is free or substantially free of (a) sugar; and (b-i) protein; and/or (b-ii) denaturing compounds; and (c) silanes.

Growing community of inventors

Garching bei Munchen, Germany

Kristina Kemter