Implementing CMC Strategies for scale-up operations in biologics manufacturing


05th October 2018 | 3PM Indian Standard Time, 10.30 AM GMT, 1130 AM CET | Dr Anita Krishnan, Assistant Director, Head, CMC development at Lupin and Dr. Annu Uppal Manager Biopharmaceutical Applications at AB SCIEX |WATCH FOR FREE

Biotechnological products are so complex, that manufacturing biologics which are both cost-effective and with best product quality, is a technical challenge. In the context of biosimilar manufacturing at each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product. Often there is remnant quality difference beyond the capability of process to address. In such instances, in-depth understanding of the process, impurities, analytical methods, the mechanism of action (MOA) of the drug substance and clinical relevance of any observed structural differences, will help in implementing novel CMC strategies. This talk will examine the elements of biopharmaceutical development that lead to successful licensure of biotherapeutics.

Presented by Dr Anita Krishnan, Assistant Director, Head, CMC development, Global Biosimilars at Lupin

Anita Krishnan presently heads a team that is responsible for physicochemical and functional characterization of biosimilars at Lupin. She is a key contributor towards the CMC of regulatory submissions to PMDA, EMA, US-FDA, TGA, Health Canada etc for several biosimilars. She is one of the core Mass Spec experts in India, who specializes in the field of advanced characterisation of biomolecules and is a Key Opinion Leader in MS software algorithms for multiple Mass Spec manufacturers. She has wide experience in the field of biosimilars and plasma therapeutics and has earlier worked at Intas Biopharmaceuticals and Celestial Biologicals. She was the recipient of DBT-BIPP research grant at Celestial Biologicals and the INSA grant as a graduate student. She has many publications to her credit and guides graduate students for PhD. She obtained her doctorate in Biotechnology from the collaborative research conducted at IICT and CCMB, Hyderabad as a CSIR fellow

 

Sponsored by SCIEX

SCIEX is a global provider of innovative LC-MS, capillary electrophoresis, and data processing technologies that assist you in dealing with biotherapeutic complexity during drug discovery, development and beyond. SCIEX innovation can help you to speed routine tasks as well as simplify your most complex characterization challenges, to achieve insights faster and with greater confidence than you ever thought possible.

Multiple Attribute Methodologies for Biopharmaceutical Characterization

Biotherapeutics are complex molecules which require strict control over manufacturing parameters to ensure safe and efficacious products. As part of the definition of these parameters, and to define the acceptable CMC strategies, assessment of how each parameter or set of parameters impacts product quality is critical. Accurately tracking the impact of process parameters on product quality attributes is critical for ensuring product quality. This talk will discuss modern analytical approaches using QTOF technology, coupled with multiple attribute methodology (MAM) software tools, for characterization and tracking of product quality attributes which contributes to successful commercialization of biotherapeutics.

Presented by Dr. Annu Uppal, Manager of Biopharmaceutical Applications at AB SCIEX

Dr. Annu Uppal received her Ph.D. in Biotechnology from the Indian Institute of Toxicology Research, Lucknow (2004) and did a post-doctoral fellowship in the School of Life Sciences, Jawaharlal Nehru University. Her experience led her to be a Senior Research Associate with Applied Biosystems, and then transitioning to Global Demo Lead and Advanced Workflow Specialist for BioPharma Applications at SCIEX. Her work focuses on biotherapeutic characterization and quantitation workflows using LC-MS technologies. Dr. Uppal has more than 25 research paper and book chapters in peer reviewed journals.

 

 

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