Abstract: Systems and devices for producing biological products and methods of using the same are provided. An example universal skid includes a rigid support and a plurality of flow-channel hardware sets. Each flow-channel hardware set couples with a respective flow channel of a plurality of flow channels for unit operations. The flow-channel hardware sets allow the flow channels to operate in parallel or in series for continuous processing over the unit operations. An example modular assembly includes one or more single-use kits for one or more unit operations and a universal skid coupled with the one or more single-use kits. An example manufacturing system includes multiple modular assemblies coupled with each other allowing continuous processing within each modular assembly, in between the modular assemblies, fully continuous processing across multiple unit operations.

Abstract: Methods for optimizing operating binding capacity for a multiple column chromatography (MCC) process are disclosed.

Abstract: Determining optimum operating binding capacity for a MCC process using one column, the process including N number of columns, comprises loading target product on a first column at a first residence time and/or flow rate; loading the product on the column at a second residence time and/or flow rate, the first residence time and/or flow rate being different than the second residence time and/or flow rate; generating a first breakthrough curve for the first residence time and/or flow rate and a second breakthrough curve for the second residence time and/or flow rate, wherein the first curve represents product breakthrough for the first column and the second curve represents product breakthrough for an Nth column; and using the curves to determine product loading capacity of the first column before product breakthrough at the Nth column; the product loading capacity of the first column equaling optimum operating binding capacity for the process.

Abstract: Methods for optimizing operating binding capacity for a multiple column chromatography (MCC) process are disclosed.