Sweety Mathew

Biography

Sweety Mathew is working as Regulatory Affairs at biocon. She completed her master's in bioinformatics and bachelors in Biotechnology. Areas of Specialisation: • Familiar with Biosimilar guidelines of EU, US, Japan, Canada and ROW markets and Medical Devices regulations • Deal with comprehensive case studies important for regulatory evaluation of Biosimilars with emphasis on clinical aspects • Coordinate pre- IND meeting requests • NOD response with the respective regulatory body • CMC, clinical & Non- clinical aspects of Recombinant and synthetic peptides • Highly motivated researcher with sound experience in molecular/cellular biology, protein biochemistry, bacteriology and microbiology, delivering efficiently in a deadline driven environment. • Well versed in primer designing and PCR techniques, Cdna preparation, Gene Transformation Methods, Gene Cloning: Desired gene amplified (PCR) product and Vector Ligation, Bacterial (E.coli)/Yeast (Saccharomyces) transformation, antibiotic selection, plasmid isolation from E.coli, Restriction digestion, Blotting Techniques (Southern and Western), SDS-PAGE for protein analysis. • Cell culture maintenance and handling of multiple cell lines, immune cell isolation, primary culture of cells and Development/optimization of protein, drug and enzymatic assays, immune cell-based assays, ELISA, Flow cytometry/ FACS, qPCR, cytokine measurements, T-cell proliferation and cellular signalling. • Conversant in conducting Protein Structure Predictions, Microarray techniques using Bioinformatics tools and database searching and Sequence alignments. • Antibody production/purification. • Gel filtration, Ion Exchange, HPLC • Fluorescence in situ hybridization (FISH), PCR, RT-PCR,

Research Interest

Bioinformatics