Pharmaceutical manufacturing methods
AssigneeKineta Two, LLC
InventorsMARK E BRANUM, Maralee McVean, Just Justesen, Eric J. Tarcha
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Abstract
The invention describes methods for manufacturing oligoadenylate synthetase (OAS) proteins for use as active pharmaceutical ingredients in pharmaceutical compositions. A manufacturing method is described that produces large quantities of concentrated, highly active OAS protein for use in pharmaceutical compositions for the treatment of a variety of diseases including viral infection. Methods for monitoring and validating the manufacturing process are also described.
Claims18
A method for producing oligoadenylate synthetase (OAS) proteins comprising:
- a) culturing a host cell containing an expression vector in growth medium under conditions wherein the OAS protein is expressed;
- b) recovering the host cell from the growth medium;
- and
- c) isolating the OAS protein from the host cell.
A method of purifying an OAS protein comprising:
- a) culturing a host cell containing an expression vector in growth medium under conditions wherein the OAS protein is expressed;
- b) recovering the host cell from the medium;
- c) isolating the OAS protein from the host cell;
- and
- d) purifying the OAS protein using affinity chromatography.
A method of purifying an OAS protein comprising:
- a) culturing a host cell containing an expression vector in growth medium under conditions wherein the OAS protein is expressed;
- b) recovering the host cell from the medium;
- c) isolating the OAS protein from the host cell;
- and
- d) purifying the OAS protein using anion exchange chromatography.
Dependencies are inferred from the claim text.