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Adapting to your manufacturing strategy

Adapting to your manufacturing strategy

Along the lifecycle of their biopharmaceuticals, our customers are facing various constraints and objectives:

  • IND stage and early clinical phases: shorten time to get your cGMP biopharmaceutical API, to initiate the next clinical trials as quickly as possible
  • Late clinical stage and pre-registration: get a validated manufacturing process
  • Launch: avoid CAPEX for building the manufacturing plant, or delay it as much as possible
  • Commercial scale: secure supply redundancy, reduce global cost of goods and continuously improve the performance of your process

Novasep Adaptive Manufacturing Strategy

With our unique range of capabilities and services, we are committed to support your evolving strategy through a broad range of options:

  • We develop and optimize your upstream and/or downstream process
  • We provide CMO services to manufacture your product in cGMP for clinical trials and to validate your process in our flexible, multipurpose facilities, including quality and regulatory support
  • We supply state-of-the-art purification equipment for clinical and commercial scale manufacturing at your facilities, or at the manufacturing site of your choice
  • We can build, validate and operate facilities dedicated to manufacture your product at commercial scale. Thanks to our strong engineering capabilities, we have a track record of time- and cost-efficient biomanufacturing plant set up
  • We develop and supply second generation, intensified processes offering substantial cost improvement, thanks to our mastery of continuous chromatography

Flexible by nature, our services can be provided according to your strategy.

  • A full range of CDMO services for ADCs
    A full range of CDMO services for ADCs
    Find out the solution adapted to your needs with Novasep's fully integrated CDMO services for ADCs
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  • A full range of services for your mAb
    A full range of services for your mAb
    Discover our full range of CDMO services for your monoclonal antibody from cell line development to ...
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  • Viral Vectors: finding the good in everyone
    Viral Vectors: finding the good in everyone
    Novasep is a reliable partner to support your clinical and commercial manufacture of viral vectors
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