Paul Cunnien - Cary NC, US Joydeep Ganguly - Boston MA, US Basav Ghosh - Cary NC, US Asif Ladiwala - San Diego CA, US Robert Song - Scituate MA, US Jorg Thommes - San Diego CA, US
Assignee:
Biogen Idec MA Inc. - Weston MA
International Classification:
B01D 15/08 B01D 35/14
US Classification:
210656, 210 85
Abstract:
The present invention provides automated systems and methods for monitoring column performance in process chromatography, and applications thereof. In an embodiment, column performance is monitored by generating a plurality of process values such as, for example, conductivity values or pH values with a detector during a chromatography step transition between a first mobile phase liquid and a second mobile phase liquid. The process values are transformed to form transformed process values in which noise present in the process values is suppressed. Column performance parameters are calculated based on the transformed process values and displayed during movement of the second mobile phase liquid through the chromatography column. The displayed performance parameters enable an operator to make a determination, for example, regarding the quality of the chromatography column packing and whether to continue the chromatography process or stop the chromatography process until the chromatography column can be repacked or replaced.
Enrichment And Concentration Of Select Product Isoforms By Overloaded Bind And Elute Chromatography
Asif Ladiwala - San Diego CA, US John Pieracci - Encinitas CA, US
Assignee:
BIOGEN IDEC INC. - Weston MA
International Classification:
C07K 1/22
US Classification:
5303873
Abstract:
Disclosed is a method for enhancing or increasing the concentration of biological product in a final mixture, wherein said biological product has one or more selected characteristics, wherein said method comprises: (a) allowing an initial mixture of biological products with and without said selected characteristics to contact a chromatography medium wherein the quantity of biological products in said initial mixture exceeds the binding capacity or the dynamic binding capacity of said chromatography medium; (b) allowing biological product not having said one or more selected characteristics to be separated by said chromatography medium; and (c) recovering a final mixture of biological products from said chromatography medium wherein said final mixture comprises an enhanced or increased concentration of biological product with one or more selected characteristics, compared to the concentration of biological product in said initial mixture.
Automated System And Method For Monitoring Chromatography Column Performance, And Applications Thereof
Joydeep GANGULY - Raleigh NC, US Basav GHOSH - Cary NC, US Asif LADIWALA - San Diego CA, US Robert SONG - Scituate MA, US Jorg THOMMES - San Diego CA, US
Assignee:
Biogen Idec MA Inc. - Cambridge MA
International Classification:
G01N 33/00
US Classification:
702100
Abstract:
The present invention provides automated systems and methods for monitoring column performance in process chromatography, and applications thereof. In an embodiment, column performance is monitored by generating a plurality of process values such as, for example, conductivity values or pH values with a detector during a chromatography step transition between a first mobile phase liquid and a second mobile phase liquid. The process values are transformed to form transformed process values in which noise present in the process values is suppressed. Column performance parameters are calculated based on the transformed process values and displayed during movement of the second mobile phase liquid through the chromatography column. The displayed performance parameters enable an operator to make a determination, for example, regarding the quality of the chromatography column packing and whether to continue the chromatography process or stop the chromatography process until the chromatography column can be repacked or replaced.
Purification Of Fkpa And Uses Thereof For Producing Recombinant Polypeptides
- South San Francisco CA, US Asif Ladiwala - San Mateo CA, US Patrick A. McKay - South San Francisco CA, US
International Classification:
C07K 1/16 C07K 16/12 C12N 9/90 G01N 33/563
Abstract:
The present invention provides methods for producing FKBP-type peptidyl-prolyl cis-trans isomerase (FkpA) polypeptides at very high levels of purity. Also provided we ultrapure FkpA and methods of using same, e.g., for use in immunoassays to show removal of FkpA from biologics produced in bacteria. In addition, the present invention provides methods of purifying polypeptides (e.g., multispecific antibodies) produced in bacteria overexpressing one or more chaperones. The methods include affinity chromatography, mixed-mode chromatography and hydrophobic interaction chromatography. in some aspects, the invention provides compositions of polypeptides (e.g., multispecific antibodies) that are essentially fee of product-specific impurities.
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