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'US 200900609501 {NN 0 cu») United States cz) Patent Application Publication — co) Pub. No.: US 2009/0060950 A1 Kistner et al. (43) Pub. Date: Mar. 5, 2009 (64) METHOD FOR PRODUCING VIRAL Related US. Application Data VACCINES. (60) Provisional application No, 60/966,724, ied on Aug. (75) Inventors: Otfried Kistner, Vienna (AT) faa ‘Christa Tauer, Vienna (AT); Noel Barrett, Klosterneubuny/ Weidling (AT); Wolfgang Mundt, Vienna G1) Inve. ay AGIK 39/148 (200601) A6IK 39/12 (200601), Comespondenee Address Ter (2006.01) BAXTER HEALTHCARE CORPORATION (52) US.CL 424/209,1; 424/206.1 ONE. BANTER PARKWAY, DF2-2E 7 DEERFIELD, IL 60015 (US) Cy) ABSTRACT ‘Tae present invention provides method forthe manfacture (73) Assignees: BANTER INTERNATIONAL of a preparation comprising virus antigens comprising a) INC, Deerfield, IL (US); BANTER inoculation of eells with infectious virus ina uid, HEALTHCARE, Wallisellen (CH) b)propagstion of sad views in sid cells ) collecting ssid propagated virus, (21) Appl.No: — 12/199,977 4) inactivating said collected virus, and €) treating said inactivated viris with a detergent, esting (22) Filed Aug. 28, 20088 ina preparation comprising viral antigens CARRIER SLEVE TANK REMOVAL OF MICROCARRIERS. ‘SEPARATOR | continuous SEPARATION (REMOVAL OF CELL DEBRIS) + —_— HARVEST TANK. BENZONASE [I MoNOVALENT VIRUS HARVEST (MVi} INFECTIOUS BENZONASE TREATMENT ForMaupenyoe || [ADDITION OF FORMALDEHYDE —— INACTIVATION TANK | * — | uvinactivaTiON UNIT | INEFECTIVE MATERIAL | UVATREATMENT FORMALDEHYDE ad AND UV-TREATED | AM UATERIAL |wonovaLent VIRUS HARVEST (vt | INAGTIVATED Patent Application Publication Mar. 5, 2009 Sheet 1 of 2 US 20090060950 AI CARRIER SLEVE TANK REMOVAL OF MICROCARRIERS | SEPARATOR CONTINUOUS SEPARATION (REMOVAL OF CELL DEBRIS) | HARVEST TANK MONOVALENT VIRUS HARVEST (MVH)| INFECTIOUS BENZONASE TREATMENT BENZONASE }-—>| FORMALDEHYDE Ri ADDITION OF FORMALDEHYDE a INACTIVATION TANK t UV INACTIVATION UNIT INEFECTIVE MATERIAL UV-TREATMENT FORMALDEHYDE I AND UV-TREATED MATERIAL MONOVALENT VIRUS HARVEST (MVH)| | INACTIVATED Fig. la Patent Application Publication Mar. 5, 2009. Sheet 2 of 2 US 2009/0060950 A1 Monovalent Virus Harvest, Sucrose Gradient Inactivated 7 Uttracentrifugation Sucrose 42% ‘ coaae Peak Pools Dilution | Homgenization ‘Benzonase Incubation Benzonase _ Ultrafiltration i Diafiltration Trton X 100 Incubation Triton X100 — Ltatitaion | Formalin Treatment Formalin — 0.025%) uwvafitation —$ _ Diaration Tween 80 Stabilization Tween 80 — Homogenization | Sterile Fittration Monovalent Bulk