Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity

Transcription

1 Alkali Resistant and Optimized Ligand for High Capacity Surface Modified Base Bead for High Purity Semi-rigid Bead for High Productivity

2 True polymer innovation that bridges amorphous materials and agarose for advanced protein separation. Protein A chromatography is widely used as the affinity capture step of both mabs and Fc-fusion proteins because of its high degree of selectivity. Variations in elution behavior of the protein A capture step requires more process development work and could have an impact on the polishing step in the downstream process. Thus minimizing the variation in elution ph between different molecules for example, makes it easier to platform the capture process. P-A PROTEIN A LIGAND High DBC via controlled conformation and orientation High alkaline stability from protein engineering P-A SURFACE MODIFICATION AND BASE BEAD FORMULATION Low HCP levels by surface hydrophilization High DBC at high flow rate Good pressure and flow properties via rigid crosslinking P-A PAGE 1

3 Outstanding Dynamic Binding Capacity 2% - 5% higher DBC compared to market standard product Impurity Clearance at Industry Standard HCP, aggregate, DNA and virus removal are in-line with market standard product Superior Caustic Stability More than 1 cycles with 15 mins and.1 N NaOH CIP show >9% DBC maintained Good Pressure Flow Properties 4 cm/hr at < 3 bar (2 cm BH, 3 cm diameter column) Attractive Economics Thanks to a higher productivity and attractive pricing, Protein A media cost can be reduced by up to 5% compared to market standard product Summary of Amsphere TM A3 Features min (g/l) 4 Alkaline Stability (%) min (g/l) Back Pressure (MPa) 4 6 min (g/l) 2 HCP (ppm) Amsphere A3 Agarose L Polymer H PAGE 2

4 Dynamic Binding Capacity mabs Dynamic Binding Capacities at 5 Minutes 6 DBC (g/l) mab1 mab2 mab3 mab4 Average Dynamic Binding Capacities of 23 Different mabs % BT DBC (mg/l) Average DBC CONCLUSION: High binding capacities at all flow rates Residence Time (min.) HPC Clearance MOLECULE HCCF ELUATE LRV mab1 mab2 mab3 mab4 mab5 35, 22, 315, 1,17, 56, 3,1 1,7 3,85 1,65 2, *Detection by HCP ELISA (Cygnus F55) PAGE 3

5 Alkaline Stability - CIP Cycling Dynamic Binding Capacity and mab Recovery CIP.1M NaOH: contact time 3 min.5m NaOH: contact time 1 min every 1 cycles 1% BT DBC (g/l) Yield (%) Yield (%) DBC is maintained at initial levels for 1 CIP cycles and Yield is above 9% and constant for 1 CIP cycles HCP and DNA Reduction 4 4 HCP Log Removal Value DNA Log Removal Value HCP reduction is approximately 2. LRV and is constant for 1 CIP cycles; DNA LRV is consistent at approximately 2.9 throughout the 1 CIP cycles Protein A Leaching and ph of Eluate 3 6 Leached Protein A /IgG [ppm] ph of Eluate Leached protein A drops to 1-2 ppm after 1 CIP There are some points under 15ppm; Elution pool ph as a function of run number is stable at approximately PAGE 4

6 Pressure - Flow Properties Linear flow velocity (cm/hr) CF 1.25 Packed bed pressure = 3 bar Packed bed pressure = 2.5 bar Packed bed pressure = 2 bar Packed bed height (cm) 2 min residence time 3 min residence time 4 min residence time 6 min residence time 24 Operating regions (2cm column i.d., CF 1.25) Linear flow velocity (cm/hr) CF 1.3 Packed bed pressure = 3 bar Packed bed pressure = 2.5 bar Packed bed pressure = 2 bar Packed bed height (cm) 2 min residence time 3 min residence time 4 min residence time 6 min residence time 24 Operating regions (2cm column i.d., CF 1.3) Protein A Leaching 7 Leached PrA (ppm/igg) mab1 mab2 mab3 mab4 mab5 *Detection by Protein A ELISA (Cygnus F74) PAGE 5

7 Protein A Mix-N-Go ELISA kit Tailored Protein A ELISA kit is available from Cygnus Technologies Protein A Mix-N-Go ELISA kit for JSR Life Sciences Ligand (Catalog # F74) Technical Properties Description Product name Matrix Average particle size 5 µm Ligand Dynamic binding capacity* 1 Amsphere TM A3 Methacrylic polymer Maximum operating pressure.8 MPa* 2 Maximum operating velocity Recommended bed height Recombinant protein A Approximately 54 mg/ml for polyclonal IgG 12 cm/h (dependent on column size) 5-25 cm Working ph range 1-13 Cleaning-in-Place stability Recommended storage buffer M NaOH 5 mm sodium phosphate buffer containing 16% Ethanol, ph 7.5 * 1 Determined at 1% breakthrough under linear velocity of 3 cm/h in a column with bed height of 2 cm. * 2 Do not exceed the column s pressure resistance. Request your free sample by sending an to your sales agent. (see contact details on back page) PAGE 6

8 Amsphere is a global trademark of JSR Corporation 218 JSR Life Sciences All rights reserved For more information visit NORTH AMERICA JSR Life Sciences JSR Micro, Inc. 128 North Mathilda Avenue Sunnyvale, CA 9489 USA bioprocess.us@jsrlifesciences.com ASIA JSR Life Sciences JSR Corporation Higashi-Shimbashi, Minato-ku, Tokyo, Japan bp@jls.jsr.co.jp EUROPE JSR Life Sciences JSR Micro NV Technologielaan 8 B-31 Leuven Belgium bioprocess.eu@jsrlifesciences.com