Methods, kits and devices for separating phospholipids and proteins from small molecules in biochemical samples can feature an apparatus having a wetting barrier, at least one frit and a separation media. For example, an apparatus can include at least one wall defining a chamber having an exit and an entrance; a wetting barrier disposed between the exit and entrance, so as to define a separation media space located between the wetting barrier and the exit and a sample receiving area located between the wetting barrier and the entrance; and a separation media disposed adjacent to the wetting barrier and having a specific affinity for phospholipids.

Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.

The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.

In certain embodiments, the invention provides a method of purifying a protein of interest from a mixture which comprises the protein of interest and one or more contaminants.

In certain embodiments, the invention provides a method of purifying a protein of interest from a mixture which comprises the protein of interest and one or more contaminants.

The present invention relates to a process for purifying crude NADPH product prepared by biocatalysis. The objective of the present invention is to solve the technical problems of low yield and low purity of the purified product in the existing ion exchange resin method. The present invention comprises sequentially the following steps: pretreatment, loading onto an ion column, elution of cations, pre-elution of impurities etc. The yield of the purification process disclosed in the present invention can be up to 85% or higher and the purified NADPH has a purity of up to 98% or higher.

The present disclosure relates to the determination of analytes in a sample using chromatography. The present disclosure provides methods of separating an analyte from a sample. The method includes introducing a sample comprising the analytes into a chromatographic system. The chromatographic system has a flow path disposed in an interior of the chromatographic system, at least a portion of the flow path having an active coating, and a chromatographic column having a stationary phase material in an interior of the chromatographic column that facilitates separation of the analytes in the sample through interaction with at least one analyte in the sample. The active coating is selected to interact with at least one analyte in the sample through (1) a repulsive force, (2) a secondary interaction, or (3) a retention mechanism distinct from the interaction with the stationary phase material.

The present invention relates to a chromatography ligand defined by the following formula R.sub.1R.sub.2N(R.sub.3)R.sub.4R.sub.5 wherein R.sub.1 is a substituted or non-substituted phenyl group; R.sub.2 is a hydrocarbon chain comprising 0-4 carbon atoms; R.sub.3 is a hydrocarbon chain comprising 1-3 carbon atoms; R.sub.4 is a hydrocarbon chain comprising 1-5 carbon atoms; and R.sub.5 is OH or H. The invention also comprises a separation matrix, comprising the described ligands coupled to a porous support, such as particles or a membrane. The ligand and matrix according to the invention is useful for purification of biomolecules or organic compounds, such as proteins, polypeptides, DNA etc. An advantageous use according to the invention is the purification of antibodies.

Processes for producing and purifying recombinant proteins are disclosed. In particular, the present disclosure provides processes of producing and purifying multi-subunit proteins expressed in yeast or filamentous fungal cells. The production and/or purification of such proteins are monitored for impurities, preferably using lectin binding assays, such that one or more process parameters may be adjusted to maximize the amount of desired recombinant protein and minimize the amount of glycosylated impurities. The processes can also be monitored for other undesired product-associated impurities, such as aggregates and nucleic acids. In exemplary embodiments, the recombinant proteins are multi-subunit proteins, such as antibodies, the host cell is a yeast, such as Pichia pastoris, and the glycosylated impurity is a glycovariant of the desired recombinant polypeptide, such as an N-linked and/or O-linked glycovariant.

Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.