Control Aggregates and Particles in Protein Based Formulations

Oliver Valet, Ph. D., rapID, Berlin, Germany

Identify aggregates and particles, from visible, subvisible to submicron in your formulation by means of Raman

The Guideline on Development, Production, Characterization and Specifications for Monoclonal Antibodies and Related products and the informal chapters of the pharmacopeia e.g. USP <1787> and USP <1790> suggestthe monitoring and investigation of aggregates by methods that are orthogonal to the pharmacopeia Methods

The following figure provides an overview ofhow the orthogonal methods cover different size ranges as well as different levels of information obtained. We adhere to highquality standards and procedures and have been successfully audited by the US FDA


Control Aggregates and Particles in Protein Based Formulations Oliver Valet, Ph. D., rapID, Berlin, Germany Identify aggregates and particles, from visible, subvisible to submicron in your formulation by means of Raman The Guideline on Development, Production, Characterization and Specifications for Monoclonal Antibodies and Related products and the informal chapters of the pharmacopeia e.g. USP <1787> and USP <1790> suggestthe monitoring and investigation of aggregates by methods that are orthogonal to the pharmacopeia Methods The following figure provides an overview ofhow the orthogonal methods cover different size ranges as well as different levels of information obtained. We adhere to highquality standards and procedures and have been successfully audited by the US FDA

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