Q. How does FlexFactory compare with KUBio?
A.
FlexFactory is a bioprocess platform using predominantly single-use technology. It comprises distinct unit operations connected via single-use tubing sets and can include a variety of automation schemes. It can be installed into appropriate new or existing workspaces. KUBio is a fast, prefabricated modular facility offering both cGMP-compliant housing and facilities together with a FlexFactory bioprocessing platform.

Q. I already have a facility. Can I install a FlexFactory platform, and how long will it take?
A.
Yes. The FlexFactory platform is designed to fit a new or an existing manufacturing plant and can be set up for production at a site of your choice. A FlexFactory installation will be fully qualified and ready to run 6 to 9 months after completing conceptual design. Conceptual design can take 2 to 3 months, so the overall project timeline is between 9 and 12 months.

Q How much space is needed to be able to install FlexFactory?
A.
The footprint of the production platform depends on the chosen configuration and your production capacity needs. The FlexFactory platform can be configured for production bioreactor scales of 200, 500, 1000, or 2000 L. A 2000 L FlexFactory setup needs a processing/manufacturing area footprint of around 400 m2 while a 500 L setup requires slightly less room.

Q. Which biologics can I manufacture?
A.
Biologics such as mAbs or vaccines can be manufactured on a FlexFactory platform.

Q. What is the process scope of FlexFactory?
A.
A FlexFactory platform gives you the necessary process equipment from cell culture expansion systems through your seed and production bioreactors to bulk drug substance formulation. Cell culture harvest clarification is performed with a harvest pump and harvest filter holder. ÄKTA chromatography systems can be incorporated for protein purification. Viral filtration is performed using a viral filtration pump and viral filtration filter holder, and then on to a final concentration TFF/UFDF system. Lastly, a solution for fill and storage of bulk drug substance is provided.

Q. What is the production capacity?
A.
Capacity is scalable from pilot production to commercial-scale production with FlexFactory. You can run up to 4 × 2000 L bioreactors with a single downstream processing train. In a mAb process, product titers are typically 2 to 4 g/L, and a 2000 L bioreactor with a process yield of 70% can be expected to have an output capacity of over 100 kg of product per year.

Q. I already have my own production process defined. Can I still install a FlexFactory?
A. 
Yes. We have extensive experience with transferring traditional stainless steel biomanufacturing processes to our FlexFactory single-use solutions. Our Fast Trak team will support your transition and can provide training using our in-house FlexFactory platform in Massachusetts, USA.

Q. How much experience do you have with installing FlexFactory platforms?
A.
This is a tried and tested process. We have installed dozens of FlexFactory processing lines around the world that are operational today. Single-use equipment in a FlexFactory can include Xcellerex bioreactors and mixers, WAVE bioreactors, and GE ÄKTA chromatography systems. We have successfully integrated Wonderware and DeltaV automation systems in a number of locations. Watch the video to see how the different elements of FlexFactory work together. See the set-up of one of our KUBio facilities, including the FlexFactory installation.

Q. Why is FlexFactory based on single-use technology?
A. 
Processing with single-use technology enables you to proceed directly to production instead of spending months performing CIP and SIP validation and qualification. Removing the need for CIP and SIP capability reduces overall plant footprint, capital cost, and the number of unit operations compared with an equivalent traditional stainless steel-based process. Additionally, single-use technology reduces changeover time between batches and is well-suited for multi-product processing needs.

Q. What GE equipment is included?
A. 
Typically a FlexFactory will include:

  • WAVE Bioreactor systems for cell culture expansion and Xcellerex XDR bioreactors for seed bioreactors and production bioreactors.
  • ÄKTA chromatography systems for protein purification operations.
  • Xcellerex XDUO and XDM Quad Mixing Systems to automate the mixing of buffers, media, and product intermediates.
Equipment within a unit operation and connections between unit operations can utilize ReadytoProcess single-use tubing. Automation hardware and software can be configured to enable monitoring, control, and analysis of the manufacturing process from multiple operator workstations and remote access for maintenance and troubleshooting by GE technicians.

Q. What non-GE equipment is provided?
A. 
The standard FlexFactory configuration typically includes an automated TFF/UFDF system and a choice of filters and filter holders for use during harvest clarification and viral clearance steps. We source these from a range of vendors. However, we can also work with you to integrate additional equipment for your specific processing needs. For added peace of mind, we offer a preventive maintenance service for non-GE equipment.

Q. What disposables will be needed to operate FlexFactory?
A. 
We will have a process review with you to explain all possible disposable solutions that GE can provide. A disposable solution will be discussed for each unit operation within the scope of FlexFactory. Disposables will include all single-use assemblies for bioreactor, mixer, and storage applications. Tube sets for all liquid transfers and downstream unit operations will be accounted for as well. Tube sets might include integral sensors or filters depending upon their intended use.

Q. Where can I find out more about FlexFactory?
A. 
If you are interested in setting up FlexFactory, please contact us to discuss potential options.