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.

The subject invention provides systems, apparatuses and methods for cultivating microorganisms and for producing microbial metabolites on a large scale. Specifically, in certain embodiments, a system comprising three separate, but connected, vessels is provided, wherein a first vessel serves as a feed tank for supplying nutrient medium to a second vessel, said second vessel serving as a submerged fermentation reactor; and wherein a third vessel serves as a collection container into which foam containing microbial growth by-products is transferred from the second vessel.

The invention relates to valve system for controlling a process fluid within a liquid processing system. The valve system comprises a valve arrangement, a pneumatic control system, and a connector unit. When the valve arrangement is connected to the connector unit, two or more valves are formed, such that the pneumatic control system controls an open/close or pressure control mode of the valves. A pump diaphragm system is disclosed, as well as a system for purifying a biological material that comprises the valve system or the pump diaphragm system. Also discloses are methods of using the valve system or the pump diaphragm system in a process for the purification of a biological material.

Methods and systems are provided to improve consistency and robustness in chromatography, for example, in operations of multi-column chromatography systems.

A process for purifying a composition comprising water, a target substance, impurities and optionally cells, the process comprising the steps (A) and (B): (A) preparing a liquid feedstock by performing step (Ai) and/or (Aii) on the composition: (Ai) removing at least some of the cells from the composition; (Aii) concentrating the composition by removing water therefrom; and (B) passing the liquid feedstock through an apparatus comprising at least two processing units, each such unit producing a product stream containing purified target substance and optionally a waste stream comprising at least some of the impurities, wherein each unit comprises specified components (i) to (v). The units may be essentially the same except for a device they contain, leading to advantages in terms of simplicity, cost and ease of operation, lower risk of operator error, easier maintenance and lower inventory of spare parts.

The present invention relates to a hybrid system of a culture and purification process for manufacturing antibody pharmaceuticals, in which one or more devices selected from bioreactor, chromatography, and filtration equipment are provided with one or more materials selected from among SU disposable bags and stainless steel (SS), and one or more devices selected from preparation and storage tanks of a medium and a buffer are provided with SS material, thereby simultaneously obtaining the advantages of a SS process system and a SU process system, and preventing cross-contamination through independent operation of a culture unit and a purification unit, and a process system is designed and positioned such that an effluent stream exiting individual culture units is introduced into one or more purification units using a control unit, thereby avoiding a bottleneck phenomenon from occurring in the purification process.

Disclosed herein is an instrument suitable for processing cells for example culturing, concentrating or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump; and a disposable processing kit complementary to the mechanical elements within the housing and comprising a fluid circuit including a fluid reservoir and plural fluid paths capable of carrying fluid flow caused by said pump(s), the instrument further including a mechanism for determining the quantity, or change in quantity of the fluid in the reservoir resulting from said fluid flow, the instrument yet further comprising a controller operable to control at least the pump and operable to perform a fault determination process, which includes the steps of determining the expected flow rate of said pump(s) calculated from the speed of the pump(s) and comparing that expected flow with the change in quantity of the fluid in the reservoir as determined by said mechanism.

An incubation chamber that may be provided in modular form in order to provide flexibility in flow rate and/or residence time of a product stream is disclosed. Assemblies including such incubation chambers for purification of biomolecules are also disclosed, as are methods for biomolecule purification, and in particular, methods for virus inactivation in an incubation chamber or in a plurality of incubation chambers arranged in series.

Apparatus for purifying a liquid comprising a target substance comprising at least two units arranged in series such that the feed stream of the second and any subsequent units comprises the product stream from a downstream unit, wherein each unit comprises specified components (i) to (vi), including a a switchable bypass assembly. Also claimed are the units and a flowpath assembly. The units may be essentially the same except for a device they contain, leading to advantages in terms of simplicity, cost and ease of operation, lower risk of operator error, easier maintenance and lower inventory of spare parts.

Provided herein are methods for purifying recombinant A Disintegrin-like and Metallopeptidase with Thrombospondin Type 1 Motif 13 (ADAMTS13) protein from a sample. The method comprises enriching for ADAMTS13 protein by chromatographically contacting the sample with hydroxyapatite under conditions that allow ADAMTS13 protein to appear in the eluate or supernatant from the hydroxylapatite. The methods may further comprise tandem chromatography with a mixed mode cation exchange/hydrophobic interaction resin that binds ADAMTS13 protein. Additional optional steps involve ultrafiltration/diafiltration, anion exchange chromatography, cation exchange chromatography, and viral inactivation. Also provided herein are methods for inactivating virus contaminants in protein samples, where the protein is immobilized on a support. Also provided herein are compositions of ADAMTS13 prepared according to said methods.