Small volume system and methods of evaluating the stability of biopharmaceutical compositions
AssigneeSartorius Stedim North America Inc.
InventorsJonathan Cutting, Thomas Mickleburgh, Nicholas Phillips, Alexander Kaiser, Friedrich Maier
Life of this patent
Estimating the term…
Abstract
An analysis container includes an outer tube and a plurality of inner tubes. The outer tube defines a buffer volume that is configured to receive a buffer material. The plurality of inner tubes is disposed within the buffer volume. Each inner tube has an inner diameter equal to or less than 6 mm and is configured to receive a biopharmaceutical composition therein. The outer tube is configured such that the buffer material and the biopharmaceutical composition are axially frozen.
Claims21
An analysis container comprising:
- an outer tube defining a buffer volume configured to receive a buffer material;
- and
- a plurality of inner tubes disposed within the buffer volume, each inner tube having an inner diameter equal to or less than 6 mm, each inner tube configured to receive a biopharmaceutical composition therein, the outer tube configured such that the buffer material and the biopharmaceutical composition are axially frozen.
A method of axially freezing a biopharmaceutical composition, the method comprising:
- activating a primary thermal electric cooler (TEC) to axially freeze contents of an outer tube including a buffer material and a biopharmaceutical composition disposed in a plurality of inner tubes disposed within each inner tube, the plurality of inner tubes disposed within the outer tube;
- set a secondary TEC at a first temperature near a freezing point of the buffer material before activating the primary TEC, the secondary TEC in thermal contact with walls of a case, the outer tube disposed within the case;
- and
- maintaining the secondary TEC at the first temperature until the buffer material and the biopharmaceutical composition are frozen.
Dependencies are inferred from the claim text.