Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab


25th January 2019 | 10.00 am GMT | Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT |BOOK FREE SEAT

Raw material and Consumable lot variability challenges during manufacturing of biosimilar Mab

Downstream processing of Biosimilar Monoclonal Antibody utilises variety of raw materials that a critical for achieving the desired product quality. In this webinar, we would like to discuss the data from three cases of lot to lot variability namely Depth filtration, Chromatographic resin and buffer component used in downstream chromatography unit operations. Changes in lots of depth filter resulted in significant clogging and differences in Host cell impurity clearance. Similarly, changes in resin lots resulted in increased back pressure during processing and variability in buffer raw material lots resulted in undesirable colouring of resin upon contact. In each case, we will present the root cause investigation, impact on product quality profile and associated CAPAs to control the effects of variability to ensure manufacturing continuity.

Presented by Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT

Sekhar Reddy is the Downstream Lead of Manufacturing Sciences and Technology for Biosimilars at Biocon Limited. He has over 10 years of experience in Research and Development, Manufacturing Plant set up, Clinical & Commercial Manufacturing and MSAT departments. In his current role, he leads the MSAT Downstream Mammalian team to support commercial manufacturing towards root cause Investigations, Process & Cleaning Validations, Risk Assessments, Extractable and Leachable studies and Alternate vendor qualifications etc.. Sekhar has extensive experience in laboratory and commercial scale equipment qualifications, MSAT lab set up, GMP, trouble shooting of manufacturing operations and support regulatory filings on CMC sections etc.

Sekhar Reddy has completed his Masters in Biotechnology from JNTU (Jawaharlal Nehru Technological Institute) Hyderabad, India.


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