MAHESH UKADE

Scientist

Datar Cancer Genetic

01.2018 - Current

Developed and maintained experimental protocols, SOPs, and technical documentation in compliance with GMP and regulatory standards.
Maintained and optimized 15+ mammalian cell lines (adherent and suspension) as preclinical models for immunotherapy, biologics, and oncology drug discovery.
Applied G-Rex 100M bioreactors and executed upstream mammalian cell culture processes (T-flasks, multilayer cell factories, suspension cultures) in cGMP cleanrooms, enabling reproducible high-density expansion for vaccine and biologics development.
Developed, characterized, and scaled mammalian cell cultures from bench research to preclinical levels, ensuring reproducibility and compliance with regulatory guidelines.
Performed validated potency assays for biologics (mAbs, vaccines), including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and viability-based functional assays.
Led immune functional assays by stimulating autologous PBMCs (T cells, NK cells) with tumor antigens and vaccine candidates to evaluate immune cytotoxicity, advancing personalized T-cell therapy research.
Specialized in developing and validating in vitro cell-based assay protocols for biosimilars, cancer vaccine QC, and immunotherapy programs.
Supported process scale-up and technology transfer by optimizing culture conditions for biologics production and cancer vaccine development.
Trained and supervised junior scientists in aseptic techniques, assay execution, troubleshooting, and GMP documentation, improving team capability and compliance.
Contributed to translational workflows by integrating potency assay data, immune functional results, and process optimization outcomes into regulatory packages and clinical readiness documentation.
Reviewed and prepared Batch Manufacturing Records (BMRs) and associated documentation to ensure compliance with cGMP.
Implemented and supported CAPA processes to address deviations and strengthen quality systems.
Actively participated in change control management for process improvements, assay modifications, and protocol updates.
Developed, revised, and trained team members on SOPs covering cell culture, assay execution, documentation, and GMP processes.
Identified root causes, performed advanced troubleshooting, and implemented solutions to resolve critical assay and instrumentation challenges, improving reliability and throughput.
Performed isolation of DNA/RNA and subcellular organelles, supporting molecular characterization and downstream analytical workflows.
Conducted ELISA (IL-2, TNF-α).
Executed microbial cell culture and handling techniques, applying aseptic practices for experimental reliability.
Applied sterilization techniques to maintain contamination-free environments for mammalian and microbial cultures.