A method for removing microorganisms from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention. Microorganisms such as bacteria, particularly B. Diminuta, are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a B. Diminuta LRV greater than about 9, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. Another method for removing microorganisms such as bacteria and Mycloplasma, includes passing the liquid through a porous nanofiber containing filtration medium having a microorganism LRV greater than about 8, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. The filtration medium can be in the form of a fibrous electro spun polymeric nanofiber liquid filtration medium mat.

The present invention relates to a method of filtrating a solution comprising von Willebrand Factor (VWF), the method comprising (a) providing a solution comprising VWF and a basic amino acid; and (b) subjecting the solution of step (a) to a virus filtration through a filter having a pore size of less than or equal to 35 nm.

A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.

A method for inactivation or removal of coagulation factors FII, FVII, FVIIa, FIX, FIXa, FX, FXI and FXIa in or from protein containing solutions obtained from blood, blood plasma, plasma fractions or by recombinant means wherein the protein containing solution is contacted with an organic acid or its salt while being stirred.

A disposable, virus-trapping membrane, and a corresponding method to remove viruses from solution are described. The membrane includes a disposable, micro-porous filter membrane and a ligand immobilized on the membrane. The ligand irreversibly and selectively binds viruses. The ligand also has a pKa sufficiently high to repel antibodies via electrostatic charge repulsion.

Compositions and methods are provided for removing viral contaminants from a chemically defined cell culture medium. Compositions provided herein are resistant to or exhibit reduced fouling by one or more components in a chemically defined cell culture medium.

The present invention relates, in some embodiments thereof, to devices and methods for decontaminating a surface of one or more vessels. In some embodiments, the devices of the invention include a first and a second chamber wherein the first chamber configured to accommodate a sterilizing substance and is fluidly connected to the second chamber, the second chamber configured to connect at least one vessel and to receive the sterilizing substance from the first chamber, wherein upon transferring the sterilizing substance to the second chamber, the surface of the at least one vessel is decontaminated.

Storage stable aqueous ready-to-administer formulations comprising isoproterenol are presented with desirable stability characteristics. In preferred aspects, formulations are terminally sterilized and packaged in a suitable format, such as a polymeric bag with metalized overwrap and include a non-contact oxygen scavenger.

A method for producing injectable pharmaceutical formulations of blood-derived protein materials includes the steps of fractioning the source material in a polymer/salt aqueous two-phase system in the presence of phenol, purifying the top phase of the system by means of precipitation with caprylic acid and purifying the bottom phase by means of thermocoagulation, increasing the purity of the materials in both phases through chromatography, removing viral particles by means of the nanofiltration of both preparations, and formulating, stabilizing, and packaging the resulting materials.

In various embodiments, the present invention provides a process for separating target proteins from non-target proteins in a sample comprising increasing the concentration of the target proteins and non-target proteins in the sample and subsequently delivering the concentrated sample to a chromatography device. In other embodiments, the invention relates to a process for increasing the capacity of a chromatography device for a target protein by delivering a concentrated sample comprising the target protein to a chromatography device.