With the integration of light and efficient baseline bioprocesses, the added value of single use technologies is increased multiple-fold, cutting process timelines and costs and lightening the regulatory burden of early stage bioprocess development and manufacturing. GMP Manufacturing is then performed in a much smaller envelope, reducing costs significantly!

  • Small Batch production (3L to 30L scale)
    Production batches are produced in small campaigns or just batch mode. All parameters are monitored, product assayed, and as much of the process profiled as possible for small batch replication, as well as process validation requirements.

    Small-scale batch production at ProteoCell can be expressed in the following cellular systems:

    • Mammalian Cell Culture (CHO, HEK, COS-7)
    • Yeast Cell Culture (with many modifications)
    • Bacterial Fermentation
  • Scale-up of process to manufacturing scale
    Depending on ultimate process size, scale-up work begins in small bioreactor scale (≤3-5L scale), and up to 30L or 50L scale for a good process profile that exhibits good robust process parameters.

    Scale-up work is typically done interchangeably between stainless steel components and disposable process solutions.

  • Pilot-scale process development and Engineering Runs
    Pilot-scale process engineering runs leading to GMP manufacturing follow the process scale-up. This is the first work in the plant, ProteoCell’s dedicated cGMP pilot plant suites. Process Engineering issues are worked out to arrive at a seamless manufacturing-grade bioprocess.
  • Pilot scale manufacturing -- non-GMP AND GMP manufacturing (planned 2013)
    Planned Pilot scale production at ProteoCell will be capped at 150L scale for the short-term. There is a possibility for expansion on a project-based scale. Pilot scale manufacturing can be done non-GMP or GMP.
    • Two fully independent complete process trains are in the works at ProteoCell. They will be a mix of stainless steel and disposable technologies integrated into one package. The process will stop at bulk filling of biologic Active Pharmaceutical Ingredients (API).
  • Technology Transfer solutions to destination manufacturing sites
    A core component of ProteoCell’s SSI platform is the design for a seamless technology transfer to a different manufacturing site. All process components, from technology, manufacturing, analytics, and supply chain, are developed in a way that allows for the successful technology transfer to an external facility after development and pilot scale manufacturing at ProteoCell. ProteoCell provides all the necessary documentation, know-how, and personnel needed to successfully transfer a process to a site outside ProteoCell’s facilities.