Abstract: Aspects of the present disclosure relate to systems and methods for manufacturing biologically-produced pharmaceutical products. Some of the systems described herein comprise an upstream component comprising a bioreactor and at least one filter (e.g., a filter probe) integrated with a downstream component comprising a purification module comprising at least a first partitioning unit and a second partitioning unit. In some embodiments; these integrated biomanufacturing systems may be operated under continuous or conditions and may be capable of efficiently producing pure, high-quality pharmaceutical products.

Abstract: Aspects of the present disclosure relate to filtration systems and methods for production of biologically-produced products, which may include pharmaceutical and/or protein products. Certain biomanufacturing systems described herein comprise a bioreactor (e.g., a perfusion bioreactor, a chemostat) and a filter probe comprising a filter bundle comprising a plurality of hollow fibers (e.g., longitudinally aligned hollow fibers). According to some embodiments, a center-to-center distance between any two hollow fibers within the fiber bundle at one or more points along a length of the fiber bundle is relatively large (e.g., greater than or equal to an average outer diameter of the hollow fibers of the fiber bundle, greater than or equal to 1.1 times a minimum diameter of the two hollow fibers). In some embodiments, the hollow fibers within the fiber bundle are arranged in an array (e.g., a hexagonal, linear, annular, or square array).

Abstract: Systems and methods for generating and evaluating candidate sequences of partitioning steps to partition at least one biologically produced product from at least one impurity. In some embodiments, a plurality of candidate sequences of partitioning steps may be generated, wherein at least one candidate sequence of the plurality of candidate sequences comprises a plurality of partitioning steps in a specified order. The plurality of candidate sequences may be evaluated. For instance, a data set associated with the at least one partitioning step may be accessed, the data set comprising: first data indicative of a behavior of the at least one biologically produced product with respect to the at least one partitioning step; and second data indicative of a behavior of the at least one impurity with respect to the at least one partitioning step. The at least one candidate sequence may be scored based at least in part on the data set.

Abstract: Aspects of the present disclosure relate to systems and methods for manufacturing biologically-produced pharmaceutical products. Some of the systems described herein comprise an upstream component comprising a bioreactor and at least one filter (e.g., a filter probe) integrated with a downstream component comprising a purification module comprising at least a first partitioning unit and a second partitioning unit. In some embodiments, these integrated biomanufacturing systems may be operated under continuous or conditions and may be capable of efficiently producing pure, high-quality pharmaceutical products.

Abstract: Aspects of the present disclosure relate to filtration systems and methods for production of biologically-produced products, which may include pharmaceutical and/or protein products. Certain biomanufacturing systems described herein comprise a bioreactor (e.g., a perfusion bioreactor, a chemostat) and a filter probe comprising a filter bundle comprising a plurality of hollow fibers (e.g., longitudinally aligned hollow fibers). According to some embodiments, a center-to-center distance between any two hollow fibers within the fiber bundle at one or more points along a length of the fiber bundle is relatively large (e.g., greater than or equal to an average outer diameter of the hollow fibers of the fiber bundle, greater than or equal to 1.1 times a minimum diameter of the two hollow fibers). In some embodiments, the hollow fibers within the fiber bundle are arranged in an array (e.g., a hexagonal, linear, annular, or square array).