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European Biopharmaceutical Review

The Next-Generation Purification of Monoclonal Antibodies




There is unprecedented pressure on the biopharmaceutical industry to improve the performance of monoclonal antibody (mAb) development and manufacturing processes. There are several factors essential to addressing this challenge, including flexibility (in which product changeover time is reduced), quality (as defined by increased robustness and reliability), speed (in which production and product release are accelerated), and cost reductions in manufacturing and capital expenditure.

Improvements in processes and productivity can enable smaller and simpler facilities and lower costs, leading to several advantages, including the ability to:

• Improve competitiveness and long-term sustainability
• Enable business models for new biologics and novel therapies
• Supply developing countries with affordable biologics
• Reach emerging markets profitably

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Gary Skarja is the Head of Membrane Chromatography R&D at Merck. He has 20 years of experience leading dynamic R&D teams in a variety of life sciences sectors, including biopharma, medical device, and cell and gene therapy. Gary holds over 20 patents related to novel polymers, devices, and processes for life sciences applications. He has Bachelor’s and Master’s Degrees in Chemical Engineering from McMaster University, Canada, and a PhD in Chemical Engineering from the University of Toronto, Canada.
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