Advances in Non-Protein A Purification Processes for Human Monoclonal Antibodies - In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a


Advances in Non-Protein A Purification Processes for Human Monoclonal Antibodies
In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a host cell protein exclusion strategy enabled robust scale up and better economics.

BioPharm International Supplements


A scalable and robust non-affinity process scheme with two ion exchange process steps provides a further opportunity to reduce the manufacturing costs for recombinant antibodies and thus the cost of goods. The two processing steps can be combined into an entirely membrane-based process scheme. The successful operation of contiguous anion and cation exchange membranes was recently reported for a commercial antibody manufacturing process.14 Even in the case of the slightly lower binding capacity of CEX membranes, the high flow rates can still offer further economic and operational advantages.

ALAHARI ARUNAKUMARI, PhD, is senior director of process development, JUE (MICHELLE) WANG, PhD, is assistant director, purification process development, and GISELA FERREIRA, PhD, is a senior process engineer, purification process development, all at Medarex Inc, Bloomsbury, NJ, 908.479.2451,


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