Our Facilities

    At Exelead, service is state of the art

    Located in Indianapolis, Indiana, Exelead operates a 56,000 square foot contract pharmaceutical manufacturing facility employing a staff of 120. Our company has a worldwide reputation for handling the contract manufacturing and contract filling needs of the small to mid-size pharma client – especially those serving small or rare disease populations. We also help clients with manufacturing and fulfillment during the clinical trial process.

     

    Our facilities play a large role in helping us fulfill that mission, by offering a flexible, scalable manufacturing environment capable of running multiple production lines simultaneously. We specialize in liposomal and PEGylated formulations, and have the staff and verification processes in place to support these complex products.

     

    Exelead has experience contract vial filling and manufacturing the following types of products:

    • Proteins
    • Antibiotics
    • Pegylated Molecules
    • Liposomal and Lipid-Complexed Molecules
    • Small Molecules
    • Buffers/Diluents
    • Suspensions
    • Aseptic preparations

     

    Our manufacturing operations utilize clean rooms qualified to GMP and ISO standards. To ensure quality, consistency, and compliance, we employ:

    • Aseptic Processing and Filling areas designed, maintained and operated to meet ISO 5 (Grade A) standards for environmental control
    • Barrier filling technology to ensure product sterility during filling and capping operations.
    • Small Scale Formulation areas designed, maintained and operated to meet ISO 8 (Grade C) standards for environmental control
    • Equipment washing and support areas designed, maintained and operated to meet ISO 8 (Grade C) local protection standards for environmental control
    • Proceduralized, standardized methodologies for HEPA recertification
    • Daily environmental monitoring of facilities, personnel and equipment to continuously verify that the facility is in a state of microbial/particulate control
    • Process/product specific bio-burden monitoring plans to ensure manufacturing process control
    • Annual environmental baseline monitoring to detect changes in the site microbial profile and confirm continuing effectiveness of sanitization agents and procedures

     

    For more information about our manufacturing facilities, or to schedule a tour, contact us.