Abstract:
In some embodiments, aspects of the disclosure relate to methods of evaluating cell culture materials, for example, nutrient materials, or other materials that can be used in cell culture media.
Abstract:
The present disclosure shows, unexpectedly, that variations in cell culture performance in large-scale cell culture systems such as, for example, those used in commercial manufacturing processes, in some instances, can be attributed to often subtle variations among shear-protectant additives used during cell culture. Assessing the quality of shear-protective additives using such large-scale systems, however, is inaccurate, time-consuming and costly. To solve the problem identified, the present disclosure provides methods and compositions for evaluating the suitability of shear-protectant additives without resorting to large scale cell growth and/or protein production tests.
Abstract:
The present disclosure relates, in some aspects, to the field of process analytical technology with respect to biotherapeutic protein production processes and products.
Abstract:
Systems, devices, and methods for the delivery of gas bubbles to liquids are generally described. The devices can include a primary conduit (102) comprising a plurality of openings (104) fluidically connecting an internal flow pathway (106) of the primary conduit to an environment outside the primary conduit. The devices may also include, in some instances, a secondary conduit (114) located at least partially within the primary conduit, the secondary conduit configured to redistribute the pressure of the gas delivered to the openings of the primary conduit, and comprising a plurality of openings (116) fluidically connecting an internal flow pathway (118) of the secondary conduit to a portion of the internal flow pathway (106) of the primary conduit outside the secondary conduit. Certain of the gas delivery systems and methods described herein are capable of delivering gas at relatively uniform linear flow velocities across multiple gas outlet openings. Certain embodiments are related to inventive configurations (e.g., spacings and/or sizing) of gas outlet openings in one or more conduits of the gas delivery device (e.g., the primary conduit and/or, when present, the secondary conduit). In addition, some embodiments are related to inventive arrangements for joining a gas delivery device is to a vessel, which may be part of for example, a reactor such as a bioreactor. Certain embodiments are related to the orientation of the gas delivery device and/or its components (e.g., during operation).