Lyophilization process for live viral compositions

• US 4,273,762 A
• Filed: 12/03/1979
• Issued: 06/16/1981
• Est. Priority Date: 12/03/1979
• Status: Expired due to Term

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Markus, Henry Z., McAleer, William J.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/099,772
• Time in Patent Office: 561 Days
• Field of Search: 424/89, 34/5, 435/235-239
• US Class Current: 424/212.1
• CPC Class Codes: A61K 2039/5254 avirulent or attenuated
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/165 Mumps or measles virus
• CPC Class Codes: C12N 2760/18434 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

Lyophilization time of live viral compositions is reduced and output per lyophilization unit is increased by lyophilizing a reduced volume of a more concentrated viral composition.

Claims

1. A method for preparing an aqueous live virus composition for subsequent lyophilization comprising

preparing a concentrated virus-diluent composition having a volume substantially less than the volume to which it is to be reconstituted at time of use, wherein the virus-diluent composition contains a phosphate salt which phosphate salt has been added to the diluent as the final ingredient.

2. A method according to claim 1 wherein after the phosphate salt is added to the diluent as the final ingredient of the diluent, the complete diluent is then added to the concentrated virus.

3. A method according to claim 1 wherein the prelyophilization volume is less than about 75% of the reconstituted volume.

4. A method according to claim 1 wherein the virus is measles virus.

5. A method according to claim 4 wherein the prelyophilization volume is less than about 75% of the reconstituted volume.

6. A method according to claim 2 wherein the virus is measles virus.