Anita Krishnan | Assistant Director
Lupin Pharmaceuticals | India

Anita Krishnan, Assistant Director, Lupin Pharmaceuticals

Anita Krishnan presently heads the Bioanalytical team at Lupin limited in Pune. In her present role she leads a team that is responsible for physicochemical and functional characterization of biosimilars. She is a key contributor towards the CMC of regulatory submissions to PMDA, EMA, US-FDA, TGA etc. She is one of the few 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.

Appearances:



Conference Day 2 @ 14:50

Practical considerations for establishing analytical similiarity in biosimilars

  • Assessment of critical quality attributes (CQA) and evaluation of tiers
  • Using risk management principles to supplement statistical approaches for assessment of analytical similarity for CQAs
  • Ranking of quality attributes based on potential impact on activity, PK/PD and immunogenicity

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