Paul E Randolph

US Patent:

20190321752, Oct 24, 2019

Filed:

Apr 19, 2019

Appl. No.:

16/389146

Inventors:

- Horsham PA, US
Paul Randolph - Malvern PA, US

International Classification:

B01D 15/16
B01D 15/20
G01N 35/00

Abstract:

A method of operating a chromatography column is described. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value.

US Patent:

20190322736, Oct 24, 2019

Filed:

Apr 19, 2019

Appl. No.:

16/389114

Inventors:

- Horsham PA, US
Paul Randolph - Malvern PA, US

International Classification:

C07K 16/24
C07K 1/22
C07K 1/18
B01D 15/20
B01D 15/38
B01D 15/36

Abstract:

A method of operating a chromatography column is described for use in methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody STELARA (ustekinumab). This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value.

US Patent:

20190324000, Oct 24, 2019

Filed:

Apr 19, 2019

Appl. No.:

16/389055

Inventors:

- Horsham PA, US
Paul Randolph - Malvern PA, US

International Classification:

G01N 30/56
C07K 16/24
C07K 1/18
C07K 1/22
B01D 15/20
B01D 15/38
B01D 15/36
G01N 30/86

Abstract:

A method of operating a chromatography column is described for use in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNFα antibody SIMPONI (golimumab). This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value.