Shashwati Atwe Ph D

• Development of a complex adjuvanted vaccine for pneumococcal infections comprising of 20+ antigens in a single formulation. • Lead role in setting up high-throughput (HTS) screening methodologies for pneumococcal vaccine candidates within the formulation line of SutroVax • Central role in planning and execution of stability studies to support technology transfer to contract manufacturing organizations. • Use of Design of Experiments’ (DoE) software to perform excipient and formulation screening for efficient selection of most promising formulations. • Contribution in development of analytical assays for analytical support to formulation development and stability studies. • Responsible for generating standard operating procedures, development reports and presentations for technology transfer within the organization and to external contract companies. • Involved in the management of supply and inputs into in vivo animal models at SutroVax.

• Design, execution, analysis and documentation of experiments to develop Virus like particles (VLP) based vaccine formulations for Chikungunya and Zika for the clinical supply production. • Scale up of various laboratory scale processes to transfer robust processes to the commercial space. • Participates in qualification and validation runs to finalize commercial vaccine process • Scientific and Technical lead to develop intra muscular and oral dosage vaccine formulations, performing excipient screening and executing a range of stability indicating assays such as thermal stability assays (DSC, CD and Fluorescence), potency assays (ELISAs, western blots, chromatographic assays) and freeze-thaw stability assays on these formulations for use in further research and development and performing preclinical as well as clinical studies. • Generating detailed written reports used for regulatory filing. • Design and conduct experiments to develop robust Lyophilization processes for vaccine products • Fill-Finish process development : container closure selection, optimizing filling and storage conditions for the vaccine product and studying the effect of various fill finish processes on stability of final vaccine product. • Analytical technical lead for development stability program • Author scientific reports that provides justification of critical process parameter measured by the critical quality attribute for VLP vaccine project • Writing standard operating procedures, and other related GLP/GMP documentation. • Reviewing data obtained for compliance to specifications and reports abnormalities.

Project 1: Determination of Suitability of Novel Biomaterials for oral protein vaccination • The suitability of pollen grains as a novel vehicle/drug delivery system for protein vaccines was investigated. • Formulation and testing of protein vaccines was done using protein antigens, excipient screening and stability testing for the protein antigens was done to enable development of a successful oral vaccine formulation and intensity of immune responses generated was measured. • Techniques used: Animal techniques (Oral gavage, blood and mucosal sample collection, injections and organ isolation), SEM imaging, Confocal imaging in vivo imaging, synthesis of polymeric particles, and immunoassays (ELISA, western and dot blot). Project 2: Investigating Interactions between Biomaterials and protein candidates in a vaccine formulation • Protein interactions in a vaccine formulation were investigated and effect on vaccine stability and performance was studied. This work was expected to enable formulation of stable vaccines in future. • Accelerated stability studies of protein antigens in presence of novel biomaterials were performed to examine protective/ degrading effects of presence of biomaterials on protein structure and activity and to establish parameters for storage and transportation conditions and shelf life of protein vaccines. • Techniques used: Protein colorimetric assays, Circular dichroism, Fluorescence spectroscopy, Gel electrophoresis, MALDI-TOF, HPLC, ELISA, Differential Scanning Calorimetry, Dynamic Light Scattering, Scanning Electron Microscope imaging. Project 3: Biomaterial Processing • Developed and optimized a protocol for chemical treatment of pollens to render them non-allergenic for use in vaccine delivery. This work enabled use of multiple species of pollen grains successfully for formulation development. • Techniques used: CHN analysis, Scanning Electron Microscope imaging, optical imaging and Fourier Transform IR Spectroscopy (FTIR-ATR).

Teaching assistant in Biochemical Engineering and Thermodynamics