Spoorthy Paladi

I am dynamic self motivated person with smartwork as my strength and believe strongly in continuous learning and to make a great contribution in the field of Biologics and Biosimilars. Work profile: *Writing CMC sections for biosimilars. *Regular interactions with SMEs, regulatory team and publishing team and updating the sections in Veeva RIMS. *Writing development, characterization, forced degradation, stability, comparability protocols and reports. * Formulation process development of highly concentrated mabs * Scale-up and technology transfer of processes in formulation and fill-finish stages * Co-ordinating filter validation studies with vendors * Execution of process characterization activities. *Experienced in areas of liquid and lyophilized protein formulations. *Design and execution of comparative forced degradation studies, Ageing, Biosimilarity assessment studies. *Perform formulation and stability support by routine analytical testing using established methodologies. *Designing of stability programs of biologicals in support of various aspects of product development (clinical, manufacturing and commercial) Analytical techniques: * Lyophilizers (Virtis advantage), HPLC (Waters and Agilent), Spectroscopic instruments: UV- Visible, Fluorescence, Scattering instruments: SLS and DLS. Areas of interest: Regulatory writing, Formulation development, Sterile filtration and validation, Scale-up activities, Technology transfer, Regulatory submissions and queries.