NOVEL PROTEIN DRUG CONJUGATE FORMULATION

Novel protein drug conjugate formulation The invention provides stable pharmaceutical formulation comprising a protein drug conjugate along with one or more suitable excipient(s) such that the formulation is devoid of any buffer components and methods of making the same. The protein drug conjugate a...

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Hauptverfasser: BANDYOPADHYAY, Sanjay, PATEL, Chintan, SINGH, Avanish Kumar, MENDIRATTA, Sanjeev Kumar
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creator BANDYOPADHYAY, Sanjay
PATEL, Chintan
SINGH, Avanish Kumar
MENDIRATTA, Sanjeev Kumar
description Novel protein drug conjugate formulation The invention provides stable pharmaceutical formulation comprising a protein drug conjugate along with one or more suitable excipient(s) such that the formulation is devoid of any buffer components and methods of making the same. The protein drug conjugate according to the present invention is antibody drug conjugate, preferably trastuzumab maytansinoid conjugate. Suitable excipient(s) according to the present invention is selected from suitable bulking agents, suitable tonicity modifiers, suitable stabilizers and the like. L'invention concerne une nouvelle formulation de conjugué protéine-médicament qui produit une formulation pharmaceutique stable comprenant un conjugué protéine-médicament conjointement avec un ou plusieurs excipients appropriés, de telle sorte que la formulation est exempte de composants tampons quelconques, ainsi que des procédés de fabrication de celle-ci. Le conjugué protéine-médicament selon la présente invention est un conjugué anticorps-médicament, de préférence un conjugué de trastuzumab-maytansinoïdes. Un ou plusieurs excipients appropriés selon la présente invention sont choisis parmi des diluants appropriés, des modificateurs de tonicité appropriés, des stabilisants appropriés et analogues.
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
title NOVEL PROTEIN DRUG CONJUGATE FORMULATION
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