Business Process Management

PRODUCTS

  • In cell and gene therapies, the process is the product. We have deep expertise developing and scaling processes for cell therapies and viral vectors, including lentiviral vectors and AAV.

  • Go bigger, stay on target, and engineer the mammalian cell lines that get the job done.

  • Connect your entire operations across internal and external sites

    Product Lifecycle Data

    Consolidate data for each stage of a drug’s lifecycle in one place.

    • Expedite compliance by centralizing product lifecycle data for each stage
    • Shorten the time between one stage to the next
    • Streamline tech transfer and accelerate to commercial rollout

    Enterprise Recipe Management

    Optimize enterprise recipe management  across environments and sites.

    • Create and manage a core set of enterprise-wide templates
    • Get access to customizable resources for every stage
    • Easily assign your templates and resources to individual sites and teams

    External Manufacturing Collaboration

    Ditch email and calls for automated communications.

    • Grant direct view-only access and batch review options as needed
    • Provide customers with a self-service approach to their sponsored batches
    • Make real-time, data-driven decisions

    Tech Transfer

    Quickly and easily move all your master resources and data.

    • Securely store batch templates, procedures, materials and equipment classes
    • Easily share process knowledge and data through transferable global recipes
    • Shift a product ad-hoc from one team to another
  • We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.

  • Manufacturing Execution System software  solutions for the Life Sciences Industry

    As a life sciences company, you want the advantages of standardization, but you need flexibility.

    Your application involves different types of users, and perhaps different sites, all with different needs. Those needs continue to evolve as your application does and so, what works today, may not tomorrow. Versatility is key; out-of-the-box content provides consistency yet must be easily configurable to address changing needs. And everything must be documented to meet stringent regulations.

WHITE PAPERS AND CASE STUDIES

NEWS