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Knowledge Center | BioReliance® Product Characterization Services | Merck
... characterization of therapeutic monoclonal antibodies (mAbs) Learn how Fab-mediated and Fc-mediated potency assays ensure successful analysis and characterization of an originator mAb and biosimilar candidate mAb. -- Early Product Characterization ... -
Lot Release and Stability Testing | BioReliance® Product Characterization Services | Merck
...Days Before your mAb therapy reaches a patient, it is important to ensure product safety and efficacy. This includes understanding the effects of environmental conditions - temperature, humidity, light, container interactions - on your mAb. We offer ... -
Interlot and Biosimilar Comparability | BioReliance® Product Characterization Services | Merck
...order structure (HOS) that renders the mAb less active or inactive. Whether your mAb is an original product or a biosimilar, our comparability studies are designed to ensure robust and reproducible mAb production, and include: Comparability between a... -
Process and Product Impurities | BioReliance® Product Characterization Services | Merck
... of a mAb. A regulatory requirement for mAbs, charge variant analysis can be evaluated by techniques including cation exchange chromatography (CEX) and capillary isoelectric focusing (cIEF). Size distribution While a single mAb product is... -
mAbsizer™ Calculator
The mAbsizer™ Calculator estimates the quantity of Merck products required to express, purify, and formulate a mAb effectively. It helps you quickly establish the end-to-end process and provides an overview for system sizing. Simply specify your final bioreactor volume and select some basic options - and off you go! -
Managing Aggregates in Your Monoclonal Antibody (mAb) Process | Merck
Aggregates in mAb therapeutics pose a risk to patients. Are you considering how best to manage and remove aggregates across your template? -
Cell Line Development | BioReliance® Product Characterization Services | Merck
...line to deliver sufficient quantities of your mAb influences its commercial potential. Used as a baseline measurement, titer is measured using Protein-A affinity chromatography (HPLC). Early in the development of a mAb, a large number of harvest cell... -
Upstream Bioprocessing - From Pre-clinical to Manufacturing | Biopharmaceutical Manufacturing | Merck
Tips and best practices for mAb upstream process development and manufacturing. -
Event | Characterizing Your Biotherapy, Burlington, 21 March 2019 | Merck
If you're involved in the development of mAb or viral therapeutics, don't miss this interactive workshop on Product Characterization and services available to you for characterizing your biotherapies.