Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process Performance - A case study to understand the impact of lot-to-lot variability of a cation exchange resin on process

ADVERTISEMENT

Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process Performance
A case study to understand the impact of lot-to-lot variability of a cation exchange resin on process performance.


BioPharm International
Volume 21, Issue 5

REFERENCES

1. Ishihara T, Kadoya T. Accelerated purification process development of monoclonal antibodies for shortening time to clinic. Design and case study of chromatography processes. J Chromatogr A. 2007 Dec 28;1176(1–2):149–156.

2. Yamamoto S, Nomura M, Sano Y. Stepwise elution chromatography as a method for both purification and concentration of proteins. Chem Eng Sci. 1992 Jan;47(1):185–188.

3. DiLeo M, Haimes E, Ley A, Chen J. Interaction of Resin-Buffer-Antibody Product Influences the development of an optimal cation exchange purification process for specific monoclonal antibody products. Dyax Corporation. 2007.

4. Cabanne C, Raedts M, Zavadzky E, Santarelli X. Evaluation of radial chromatography versus axial chromatography, practical approach. J Chromatogr B. 2007 Jan 15;845(2):191–199.

5. Janson JC, Ryden L. Protein purification-principles, high resolution methods, and applications. New York: Wiley-VHC; 1998.

6. Carta G, Ubiera A. Particle size distribution effects in batch adsorption. AICHE J. 2004;49(12):3066–3073.

7. Karau A, Benknen C, Thommes J, Kula MR. The influence of particle size distribution and operating conditions on the adsorption performance in fluidized beds. Biotechnol Bioeng. 1997 Jul 5:55(1):54–64.

8. Billen J, Davy D, Rudaz S, Veuthey JL, Ritchie H, Grady B, Desmet G. Relation between the particle size distribution and the kinetic performance of packed columns: Application to a commercial sub-2 μm particle material. J Chromatogr A. 2007 Aug 17;1161(1–2):224–233.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here