Sandeep Zode

Leading product design and monitoring product performance from early-stage to late-stage development for sterile liquid/gels for intravesical and lyophilized granules for oral drug delivery. Decision maker for selection of drug delivery, identification of stagewise risks and mitigation strategies. Implementation and successful establishment of new processes for product scale-up.

Led design and development of sterile liquid and lyophilized formulations of anticancer drugs for the regulated market. Successfully transferred the two lyophilized products (solution and suspension) from lab scale to manufacturing scale for the regulated market. Used QbD principles while designing and scaling up the aforementioned formulations to obtain robust product. Mentored research project for junior team members. Successfully implemented controlled ice nucleation technology in lab scale lyophilizer.

Worked on development of 505b2 formulations for regulated market. Designed and established proof-of-concepts for three drug molecules (nasal solution and injectable suspension and emulsions) in the animal model. The projects have been successfully translated to patented formulations. Fortunate to contribute as a team member for the formulation TosymraTM (sumatriptan) nasal spray, a differentiated formulation approved under 505b2 filing by USFDA, Jan 2018.