Q. How does FlexFactory™ compare with KUBio™?
A. FlexFactory™ is an agile 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 prefabricated modular facility when combined with a FlexFactory™ bioprocessing platform inside for rapid, flexible cGMP-compliant manufacturing.
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™ platform 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™ manufacturing line?
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™ platform 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™ platform?
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 and into aseptic filling of drug product. 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 and most recently robotic aseptic filing is available.
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™ platform?
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 and our OptiRun™ team will support your line into the future.
Q. How much experience do you have with installing FlexFactory™ platforms?
A. This is a tried and tested process. We have installed over one hundred FlexFactory™ processing lines around the world that are operational today. Single-use equipment in a FlexFactory™ line can include Xcellerex™ bioreactors and mixers, WAVE™ bioreactors, and Cytiva 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™ manufacturing linework together.
Q. Why is FlexFactory™ solution 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 Cytiva equipment is included?
A. Typically a FlexFactory™ solution 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. Figurate™ 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 Cytiva technicians.
Q. What non-Cytiva equipment is provided?
A. The standard FlexFactory™ platform 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-Cytiva equipment.
Q. What disposables will be needed to operate FlexFactory™ manufacturing line?
A. We will have a process review with you to explain all possible disposable solutions that Cytiva 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 a FlexFactory™ solution to fit my needs?
A. If you are interested in setting up FlexFactory™ platform, please contact us to discuss potential options.
- Find out more about the configurable or customized hardware and software used in FlexFactory™ automation
- See more about how FlexFactory™ works in a KUBio™ facility
- Why ensuring security of supply in bioprocessing matters
- Download the Enterprise Solutions brochure
- Download the Automation preventive maintenance flyer
- Learn more about Cytiva's Automation platforms