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US 2013/0199734 A1Published application
Method for manufacturing protein solutions and their concentration
AssigneeBoehringer Ingelheim International GmbH
InventorsTorsten SCHULTZ-FADEMRECHT, Stefan BASSARAB, Patrick GARIDEL
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Abstract
The invention relates to a method for preparing highly concentrated liquid protein formulations. They are prepared by concentrating a protein solution by carrier gas drying at a reduced process pressure.
Claims19
1) A method for concentrating a protein solution, comprising the following steps:
- a. preparing a protein solution,
- b. optionally transferring the protein solution from (a) into individual containers,
- c. transferring the protein solution from (a) or the individual containers from (b) into an apparatus comprising the following components:
- i. process chamber (7),
- ii. vacuum pump (8),
- iii. gas connection (1),
- iv. at least one inlet (5),
- v. at least one outlet (6),
- vi. flow sensor (3),
- vii. pressure sensor (4),
- viii. at least two valves (2),
- ix. optionally a perforated plate (10),
- x. optionally a recirculating pump (11) for protein solution (9) and bypass with connections (12) and (13),
- d. applying a carrier gas current to the apparatus from step c), wherein
- i. the process pressure is reduced,
- ii. the flow rate of the carrier gas is uniform,
- e. removing the concentrated protein solution or the individual containers from the apparatus according to method step c).
14 more elements
18) A method for measuring a protein concentration in a protein solution comprising the following steps:
- a) preparing a protein solution with a defined protein concentration cA in an individual container, the protein solution optionally being free from adjuvants,
- b) measuring the weight mB of the protein solution including individual container,
- c) transferring the protein solution in the individual container from (b) into an apparatus comprising the following components:
- i. process chamber (7),
- ii. vacuum pump (8),
- iii. gas connection (1),
- iv. at least one inlet (5),
- v. at least one outlet (6),
- vi. flow sensor (3),
- vii. pressure sensor (4),
- viii. at least two valves (2),
- ix. optionally a perforated plate (10),
- x. optionally a recirculating pump (11) for protein solution (9) and bypass with connections (12) and (13),
- d) applying a carrier gas current to the apparatus from step c), wherein
- i. the process pressure is reduced,
- ii. the flow rate of the carrier gas is uniform,
- e) removing the concentrated protein solution in the individual container from the apparatus according to method step c),
- f) measuring the weight mF of the protein solution including individual containers,
- g) determining the quotient of the measurements obtained from method steps (b) and (f):
- me/mF,
- h) calculating the protein concentration of the concentrated protein solution for example according to the following equation:
- cH=mB/mF*cA
19 more elements
Dependencies are inferred from the claim text.