Preclinical Development

    Perfect your formulation and analytical test methods.

    Develop a scalable formulation for your drug product and solidify your analytical test methods. Work with our team and leverage:

     

    • Decades of experience working specifically with lipid-based solutions
    • Advanced analytical testing equipment
    • A smooth transition from preclinical development to process scale up, clinical batch and cGMP manufacturing.

     

    During the entire 25+ years we have been manufacturing drug product at our Indianapolis manufacturing site, we have always focused on two core technologies: lipid-based formulations and PEGgylation. We have strategically placed ourselves as a niche pharmaceutical company, providing end-to-end service for clients that operate in this market. Because we maintain integrity to this focus, we continue to operate as industry experts.

     

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    Preclinical Development at Exelead includes:

    • Raw Materials Selection
    • Formulation Development
    • Analytical Method Development
    • Design of Experiments
    • Pilot Batches
    • Manufacturing Process Optimization & Development
    • Analytical / Microbial Method Suitability, Feasibility & Robustnes

     

     

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