Manufacturing

Experience

  • Expertise in both Autologous and Allogeneic cell therapies
    • Sanjeev possesses extensive manufacturing experience in logistically intricate autologous cellular therapies, including Dendreon’s Provenge, as well as allogeneic cell therapies, such as Nohla Therapeutics NLA-101. 
  • FDA approved Commercial stage and Clinical stage startup experience
    • At Dendreon Sanjeev worked with Provenge, which was FDA approved and commercially available.
    • At Nohla Therapeutics he managed the Phase II clinical manufacturing of NLA-101.
  • Experience setting up manufacturing operations in a startup environment
    • At Nohla Therapeutics, Sanjeev was responsible for the comprehensive development and management of all manufacturing operations. This included overseeing procurement, warehousing, manufacturing processes, research flow cytometry, and clinical distribution.   
  • Pharmaceutical Batch Record Optimization
    • At Dendreon, Sanjeev was involved with streamlining the batch record for Provenge. Subsequently, at Nohla, he applied the efficiencies gained from Dendreon and developed a more efficient and concise batch record for NLA-101.
  • Aseptic Process Validation experience
    • Sanjeev possesses extensive expertise in managing an Aseptic Process Validation program, acquired during his tenure at Dendreon. He was instrumental in a substantial project aimed at overhauling Dendreon’s APV program while ensuring compliance with FDA regulations.
  • CMO Site Evaluation and Selection
    • At Nohla Therapeutics, Sanjeev was a member of a team responsible for evaluating and selecting a Contract Manufacturing Organization (CMO) for the Phase III manufacturing of NLA-101. This entailed conducting due diligence visits to multiple CMO sites and providing technical support to Quality during their own site inspections.