Back to results
US 8,603,796 B2Granted
Method for producing storage stable viruses and immunogenic compositions thereof
AssigneeWyeth
InventorsJee Loon Look, Vladimir G. Frolov, Nandini Konar
Life of this patent
Estimating the term…
Abstract
The invention relates to methods for producing storage stable virus compositions. In certain embodiments, the invention relates to one or more formulations and process steps which result in storage stable virus compositions, wherein the composition is storage stable as a lyophilized solid composition or a frozen liquid composition.
Claims18
A process for producing a storage stable virus composition, the process comprising:
- (a) freezing a virus composition comprising a respiratory syncytial virus (RSV), a parainfluenza virus (PIV), or a combination thereof below its glass transition temperature in a time of 60 minutes or less at a rate of −0.5° C. to −2.5° C. per minute;
- and
- (b) lyophilizing the virus, wherein the lyophilized virus composition has less than about a 17.6% log PFU loss after at least one year at a storage temperature of about 1° C. to about 10° C. as compared to the lyophilized virus composition before storage.
A process for producing a lyophilization stable bulk volume virus composition, the process comprising:
- (a) placing a liquid virus composition having a volume of at least 50 mL in a lyophilization tray, wherein the virus composition comprises respiratory syncytial virus (RSV), a parainfluenza virus (PIV), or a combination thereof;
- (b) freezing the virus composition below its glass transition temperature for at least about 20 minutes in a liquid nitrogen bath;
- and
- (c) lyophilizing the virus composition,
- wherein the lyophilized virus composition has less than about a 0.5 log PFU loss relative to the virus composition before lyophilization.
2 more elements
Dependencies are inferred from the claim text.