Methods of purifying and producing an adalimumab antibody

The present invention relates to a method for purifying adalimumab or a biosimilar thereof from a sample comprising adalimumab or a biosimilar thereof and impurities, through the use of hydroxyapatite resin in a Bind/Elute (B/E) mode under conditions such that the adalimumab or a biosimilar thereof...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser:	Costioli, Matteo, Broly, Hervé, Sutter, Harry-James
Format:	Patent
Sprache:	eng
Schlagworte:	CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOIDCHEMISTRY CHEMISTRY HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE METALLURGY ORGANIC CHEMISTRY PEPTIDES PERFORMING OPERATIONS PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SEPARATION THEIR RELEVANT APPARATUS TRANSPORTING
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Beschreibung
Zusammenfassung:	The present invention relates to a method for purifying adalimumab or a biosimilar thereof from a sample comprising adalimumab or a biosimilar thereof and impurities, through the use of hydroxyapatite resin in a Bind/Elute (B/E) mode under conditions such that the adalimumab or a biosimilar thereof binds to the resin and at least a portion of the impurities remain unbound. The invention is also concerned with a pharmaceutical compositions=of the purified adalimumab or a biosimilar thereof, and adalimumab or a biosimilar thereof obtainable by the process of the invention.