Shulagna Sharma

Department of Biophysics, Faculty of Medicine, Centre for Integrative Physiology and Molecular Medicine (CIPMM) | Thesis under review, awaiting defence Designed and optimized primary human immune-cell assays in 2D/3D tumour models using high-content imaging and multicolour flow cytometry. Investigated NK-cell cytotoxicity, migration, infiltration and mechanosensing in ECM-mimicking matrices. Developed automation-compatible 96/384-well workflows and trained researchers.

Independently executed 10 concurrent GMP cell-banking projects for Amgen oncology, inflammation and ATO teams, delivering ~300 QC-verified vials from 10 cell lines, including luciferase and HiBiT/KRAS knock-in models, for ADCC, bioluminescence and target-engagement assays. Achieved 100% sterility/mycoplasma pass rate; rescued an at-risk line from 18% to >96% viability and developed a client-adopted dissociation protocol. Coordinated ATCC STR testing & authored all 10 Certificates of Analysis for delivery.

Led development, qualification and validation of seven Biacore T200 SPR methods for Bevacizumab biosimilar MYL-1402O, assessing VEGF-A target binding, Fc-receptor engagement, affinity and kinetics. Authored reports for the biosimilarity package supporting Abevmy/Lextemy approvals across multiple solid tumours; work was published in Expert Opinion on Biological Therapy (2022). Partnered with Cytiva to resolve instrument failures, enabled transfer under FDA/EMA standards and trained a junior scientist in SPR.

Delivered IND-enabling functional characterization across four biosimilar programmes: Bevacizumab, Adalimumab, Trastuzumab and Rituximab. Restored a Phase III-critical Rituximab ADCC potency assay by resolving NK-cell/PBMC donor variability, meeting the U.S. FDA filing deadline. Led Biacore T200 SPR and ELISA-based Fc/Fab characterization, DoE-driven bioassay optimization and transfer to GMP QC. Authored dossier-ready reports supporting the Rituximab regulatory package; promoted for innovation and delivery.

Developed and qualified cell-based potency and ligand-binding assays for Adalimumab, Bevacizumab and Trastuzumab across QTPP, toxicology and preclinical stages. Created a ready-to-use U937 caspase-luminescence anti-TNF-alpha assay, cutting runtime from 18 to 5 hours while maintaining specificity and accuracy. Validated an L929 potency assay for DS/DP and stability testing. Established GMP frozen cell/PBMC banks, supported formulation studies and authored QA-approved protocols, reports, SOPs and STPs for QC.

Supported the start-up of Kemwell's new Biopharmaceutical Unit, establishing GMP-compliant cell-culture, bioanalytical, and microbiology QC capabilities within a biologics CDMO. Executed cell-based proliferation, inhibition and reporter-gene assays; ligand-binding assays; HCP/HCD impurity testing; ELISA/qPCR; and mycoplasma/endotoxin testing. Managed GMP documentation, stability studies, OOS investigations and CAPA workflows, building an industry foundation in biologics quality control and assay operations.

Investigated how sperm post-translational modifications influence capacitation and infertility using molecular biology and proteomics-based approaches in a hamster model. Conducted cloning and gene-expression studies, recombinant protein expression in E. coli and small-scale protein purification. Managed experimental workflows, sample preparation, data documentation and laboratory activities within a multidisciplinary team-based reproductive-biology project at CSIR-Centre for Cellular and Molecular Biology.

Title of Project: Screening of Dietary Constituents for Proteasome Inhibitory Activity The project was part of my master’s thesis done under the guidance of Dr. Ayesha Ismail, Dept. of Biochemistry. Screening of dietary constituents from different food groups consumed in the Southern part of India that is reported to be rich in phenolic content, namely green leafy vegetables, fresh fruits, dry fruits, and spices for total phenolic and flavonoid content and proteasome-inhibitory activity.