Yoga Laksha Email & Phone Number

Chennai, Tamil Nadu, India

Bengaluru Area, India

• Developed and optimized the downstream process for a novel fusion therapeutic monoclonal antibody (Human IgG & Mouse IgG - CHO cell lines) targeting cancer cells. ( Biologics & Biosimilars)• Implemented the Impurity Reduction proposal for internal regulatory submission (Protocol & Report writing, study execution, Data Review & Report approval).• Authored for Protocol generation ,Study Execution, Report writing , assisted for QA review & approval of supportive documents for IND filing (US FDA)• Prepared the SOP s & IOP s & Provided training to make the document as effective for the laboratory use as per the QMS guidelines• Executed Performance Qualification(PQ),responsible for the Protocol & Report authoring, Data Review & Report approval.(AKTA Pure instrument)• Screening of Optimization of High throughput small scale purification methods • Streamlined in the precipitation removal activities in Drug substance to overcome challenges • Contributed for the characterization study of charge variants for development stage clinical trial Drug Product. • Executed Dynamic Binding Capacity comparative study for the various resins • Coordinated with the cross functionality team for the material transfer from MFG site to R&D site through Inter Office Memo• Guided interns for the proper execution of the purification, process development & closure of their project report Hands on Experience on:Chromatography systems (AKTA avant, AKTA Pure, AKTA explorer & AKTA prime), Sonicator, Turbidometer, Cedex Bio, Centrifuge, UV visible spectrophotometer, Solo VPE, NanoDrop, Tangential Flow Filtration, Depth Filtration