Regulatory/QbD
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Considering Process Scaling for mAbs During Early Phase Development Monoclonal antibody processes must perform consistently across scales from hundreds of milliliters to thousands of liters.
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Address the complexity of protein characterization Use Biacore™ surface plasmon resonance (SPR) systems for assessment of drug potency (EC50) and stability.
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Principles & Methodology Handbooks
Find practical tips and in-depth information about common methodologies used in the lab.