Asahi Kasei Medical Co., Ltd.

Tomoko Hongo

Ryo Hamamoto

Yusuke Kon

Fujiharu Nagoya

Masayasu Komuro

Naoko Hamasaki

Shoichi Ide

Hirohisa Hayashida

Mitsunori Kubozaki

Akika Futamura

Fumihiko Yamaguchi

A virus removal membrane includes cellulose, and a primary-side surface through which the protein-containing solution is to be applied and a secondary-side surface from which a permeate that has permeated the virus removal membrane is to be flowed, wherein a bubble point is 0.5 MPa or more and 1.0 MPa or less; and when a solution containing gold colloids having a diameter of 30 nm is applied through the primary-side surface to the virus removal membrane to allow the virus removal membrane to capture the gold colloids for measurement of brightness in a cross section of the virus removal membrane, a value obtained by dividing a standard deviation of a value of an area of a spectrum of variation in the brightness by an average of the value of the area of the spectrum of variation in the brightness is 0.01 or more and 0.30 or less.

Virus removal membrane and method for manufacturing virus removal membrane

A virus removal membrane is formed from a hydrophilized synthetic polymer, in which, when a solution containing gold colloids having a diameter of 20 nm is applied through a primary surface to the virus removal membrane to allow the virus removal membrane to capture the gold colloids for measurement of brightness in a cross section of the virus removal membrane, a value obtained by dividing a standard deviation of a value of an area of a spectrum of variation in the brightness by an average of the value of the area is 0.01 or more and 1.5 or less; and a thickness of a portion, where gold colloids having a diameter of 20 nm or more and 30 nm or less are captured, in the cross section of the virus removal membrane in a wet state is 10 &#x3bc;m or more and 30 &#x3bc;m or less.

Virus removal membrane

A virus removal membrane is formed from cellulose, in which, when a solution containing gold colloids having a diameter of 20 nm is applied through a primary surface to the virus removal membrane to allow the virus removal membrane to capture the gold colloids for measurement of brightness in a cross section of the virus removal membrane, a value obtained by dividing a standard deviation of a value of an area of a spectrum of variation in the brightness by an average of the value of the area is 0.01 or more and 1.5 or less; and a thickness of a portion, where gold colloids having a diameter of 20 nm or more and 30 nm or less are captured, in the cross section of the virus removal membrane in a wet state is 10.0 &#x3bc;m or more and 30.0 &#x3bc;m or less.

The present invention provides a method for manufacturing a virus-free protein drug, comprising (a) a filtration step of filtering a virus-containing protein solution through a small-pore size virus removal membrane to obtain a virus-free protein solution, the filtration step (a) comprising (q) a low-pressure filtration step of filtering the solution through the small-pore size virus removal membrane at a filtration pressure of 0.30 kgf/cmor lower to obtain the virus-free protein solution, wherein the solution prior to filtration in the low-pressure filtration step (q) has a pH (X) and a salt ionic strength (Y (mM)) that satisfy the following equations 1 and 5: 0&#x2266;Y&#x2266;150X&#x2212;590 (Equation 1) and 3.5&#x2266;X&#x2266;8.0 (Equation 5) or the following equations 4 and 5: Y=0 (Equation 4) and 3.5&#x2266;X&#x2266;8.0 (Equation 5).

Method for manufacturing protein drug

An object of the present invention is to provide a method for removing even small viruses from a high concentration monoclonal antibody solution using a membrane, and thus for recovering the antibody within a short time at high yield in the form of a filtrate. The present invention provides a method for producing a preparation containing a monoclonal antibody, which comprises a step of removing viruses by filtering viruses in a monoclonal antibody solution using a virus-removing membrane, wherein

Method for removing viruses from high concentration monoclonal antibody solution

A colloid solution that exhibits storage stability and pH stability, being useful as viral substitute particles for use in an integrity test for virus removal membrane. In particular, a metal colloid solution characterized in that it comprises metal particles or metal compound particles of 1 to 100 nm average diameter, a water soluble high-molecular-weight dispersant having an N group and water and/or a water soluble organic solvent, the metal colloid solution being stable for a prolonged period of time and being stable in at least pH values ranging from 4 to 11.

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Tokyo, Japan

Tomoko Hongo