Transformational Science: Moving from Challenges of High Concentration Protein Formulations Development to Meet the Needs of High Potent Bispecifics


19th March 2019 | 10.00 am EST | Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SA |BOOK FREE SEAT

Monoclonal antibodies (mAbs) have significantly contributed to the treatment of oncological and immunological disorders over the last two decades. Next advancement in this line is the introduction of bispecific antibodies – molecules which can bind to two different receptors at the same time. Engaging T-cells to target tumour cells and eventually killing tumour cells have been clinically demonstrated by such bispecific antibody. Traditionally one of the key challenges for developing mAbs is to administer high quantities of mAbs, on the other hand, bispecific antibodies are extremely specific and more efficient, which makes them highly potent – leading to a reduced dose. This turns the focus from developing high concentration formulations for mAbs to the development of low concentration formulations. Scientific challenges are of very different nature with surface adsorption being the key challenge; during drug product manufacturing as well as during clinical dosing protein molecules encounter various different surfaces and preventing/controlling adsorption on any of these surfaces is important. Analytical methods are also required to be adapted for reliable low concentration measurement for the drug product as well as the diluted preparation for infusion in the clinic.

Presented by  Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SA

Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation, analytical and drug product development unit. His current responsibilities include designing and executing product development and characterization strategies for both early and late-stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He has ~ 12 years of experience in biopharmaceutical formulation and analysis. His principal research interests are protein formulation, stabilization, combinational product development, analytical characterization, DOE and QbD. He also has a keen interest in practising lean principles. He has received multiple research awards and has several publications and presentations to his credit.


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