Devendiran D Email & Phone Number

Bengaluru, Ka, In

Ahmedabad, Gujarat, India

Upstream processing of mammalian Cell Culture for manufacturing Biosimilars

Bengaluru, Karnataka, India

1.Commissioning and qualification of equipment & facility in eVLMS.2.Planning, executing, monitoring and controlling the cell culture operations as specified in the BMRs / SOPs.3.Operation of equipment’s like bioreactor, ATF, Refrigerator, Dynamic Pass box, Peristaltic pump, Weighing Balances / Scales. Operation & verification of Analytical instruments like pH and Conductivity Meter, Integrity Testing Machine, Automatic cell counter, Microscope, Osmometer & Metabolite analyzer.4.Initiation of notifications in SAP for instruments/equipments breakdown & follow-up. To performing SAP transactions for processes needed in Production Department.5.Perform equipment cleaning. Good at process cleaning change over strategies (CIP/SIP)6.I am knowledgeable about and skilled in using the following tools: the Cedex Bio Metabolite Analyzer, The Automatic Cell Counter, The Osmometer, The Integrity Machine, The Phase Contrast Microscope,Biosealer,Blood-Gas Analyser,Biowelder pH meter and Centrifuge.7.Mammalian cell culture development from 50L seed bioreactor to 6kL productionbioreactor.8.Single use bioreactor operations- Pre checks, Bag Inflation, Media intake and inprocess monitoring (50l &200l)9. SS bioreactor operations- CIP, PHT, ESIP of bioreactors, Media intake and Inprocess Monitoring (1kL & 6kL)10. Bioreactor operations, bio welding, sealing and connection preparations.11.In process sampling and their analysis (Offline pH, offline pCO2,Osmolality, Viable cell concentration and viability12. Real time completion of BMR and supporting documents.13. Commissioning and qualification of 1kL& 6kL bioreactors (BioEngineering),Single use bioreactors (Merck Millipore), and bioreactors supporting labequipment. (SAT, IQ, OQ, PQ, DB and PV)14.Preparation of SOPs, protocols, qualification documents, reports, QMS elements.15. I have knowledge and working experience on upstream process of Trastuzumab,Bevacizumab,Itolizumab and Pertuzumab.

Bangalore

I have done my training at GPP Biosimilar – PEG GCSF Upstream process. I have understood fermentation process and principle involved, and learnt operation of Biosafety cabinet, over headed stirrer, Polytron blender & centrifuge. I got basic knowledge of upstream process including fermenter SIP ad CIP, media preparation, Vial inoculation etc.