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KUBio Biomanufacturing Solution

Worldwide demand for biopharmaceuticals is increasing dramatically. This requires a new strategy to meet this growing need.

KUBio biomanufacturing solution is that strategy. KUBio creates biomanufacturing capacity by delivering a fully functional, ready-to-run facility in 14-18 months. Predesigned to meet cGMP requirements, KUBio helps biopharmaceutical manufacturers respond rapidly to local healthcare needs. KUBio also supports global biomanufacturers in bringing life-saving treatments to market more quickly.

KUBio biomanufacturing solution is one component of GE’s Enterprise Solutions. KUBio consists of prefabricated modules equipped with the heating, ventilating, air conditioning (HVAC) system and all the piping necessary to run a biomanufacturing plant. The facility can be equipped with an integrated FlexFactory single-use manufacturing platform, or a hybrid processing platform.

The other components of Enterprise Solutions include:

  • Fast Trak services for end-to end support from process development to transplant support to qualification and training.
  • Ongoing equipment life cycle services.
  • Business guidance.
  • One point of contact project management.

 

Your Process Equipment Your Facility Your Services Your Investment

KUBio is equipped with the FlexFactory biomanufacturing platform which reduces operational costs by enabling faster deployment, accelerated production turnaround, multiproduct processing, and scalable production.

  • Integrated platform
  • Connectivity with single-use tubing sets
  • Single-use technology
  • More than 100 kg of MAbs per year
  • Centralized monitoring and control enabled for 21 CFR part 11 compliance

KUBio modular units provide a fully-functional bioprocessing facility designed to deliver a rapid response to local healthcare requirements:

  • cGMP compliant design
  • Footprint: 1210 m²  
  • Modular construction
  • Total area: 2200 m²
  • Fully qualified up to OQ
  • Flexibility for three to five products
  • Two levels: manufacturing and HVAC  
  • FlexFactory Process equipment transfer
  • FlexFactory Process equipment SAT
  • FlexFactory Process equipment FAT
  • Installation/Operational qualification
  • Equipment start-up
  • Training

In addition, we provide a range of services that complement the specific needs of your project in process development, clinical material, bioprocess training, and financing solutions.

GE Healthcare is a well-established and financially stable organization owned by General Electric Company. Our presence in more than 100 countries, know-how, and partnerships with industry-leading suppliers bring expertise to every step of your manufacturing project.

For complete peace of mind, we manage every aspect of your KUBio project from offsite prefabrication to onsite equipment start-up and ensure your investment is fixed and known from the start.