Bio-Rad cPrime Media User Manual

Nuvia™ cPrime
Hydrophobic
Cation
Exchange Media
Instruction
156-3401 156-3404 156-3402 156-3405 156-3403 156-3406
numbers
Manual
Please read the instructions in this manual prior to using Nuvia cPrime hydrophobic cation exchange media. If you have any questions or require any further assistance, please contact your Bio-Rad Laboratories representative.
Table of Contents
Section
Section
Section
Section
Packing Small
Packing Process Scale
Flow Properties
Buffers
Section
Section
Section
Section
Section
Section
1:
Introduction 1
2 :
Technical Description 2
3 :
Preparation
4 :
Column
Columns
5 :
Column Packing Evaluation 7
6 :
Method Development
7 :
Sanitization
8 :
Storage 11
9:
Regulatory Support 11
10: Ordering
Packing
Information
Columns
and
8
Regeneration 10
11
3
3
3
4
5
6
Section
1
Introduction
Nuvia™ cPrime™ hydrophobic cation exchange media are designed for the process scale purification of a wide variety of therapeutic proteins. Nuvia cPrime media’s unique selectivity allows method developers to use hydrophobic and cation exchange interaction modes to achieve effective purification. More importantly, the media have a wide design space for binding and elution, allowing for the development of highly robust methods in a commercial manufacturing setting. Nuvia cPrime media are built on a rigid, mechanically and chemically stable macroporus base matrix with a particle size optimized to deliver exceptional flow properties, fast mass transfer, and stability. See the Nuvia cPrime media product information sheet for more product details.
If you have questions or require methods development assistance with Nuvia cPrime media, contact your local Bio-Rad process chromatography representative or the Bio-Rad chromatography technical support group for assistance at 1-510-741-6563.
1
Section
2
Technical
Table 1. Nuvia™ cPrime™ media technical description.
Functional group Hydrophobic cation exchanger
Base matrix composition Macroporous highly crosslinked
Particle size 70 µm ± 10 µm
Dynamic binding capacity* ≥ 40 mg/ml
Ligand density 55–75 µeq/ml
Recommended linear flow rate range
Pressure vs. flow performance**
pH stability 2–14 short term
Chemical stability 1.0 N NaOH, 1.0 N HCl, 25%
Shipping solution 20% ethanol
Storage conditions 20% ethanol
Shelf life*** 5 yrs
Description
hydrophilic polymer
50–600 cm/hr
Under 2 bar @ a flow rate of 600 cm/hr
3–13 long term
HOAc, 8 M Urea, 6 M Gu-HCl, 6 M KSCN, 3 M NaCl, 1% Triton X-100, 2% SDS + 0.25 M NaCl, 20% ethanol, 70% ethanol, 30% isopropanol
* at 10% breakthrough hIgG.
** 20 cm X 20 cm packed bed (1.17 compression factor). *** Stored at room temperature in 20% ethanol under accelarated conditions.
2
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