By: Emmanuel Ligner, Danaher Group Executive and President and CEO of Cytiva
New genomic technologies such as mRNA, antisense oligonucleotides, and cell and gene therapies have propelled biomanufacturing into a period of rapid evolution. Cell and gene therapies are expected to experience an astounding 33% compound annual growth rate by 2026.[i]
Innovation in this space is moving faster than the technology to support it. Manufacturing facilities designed around today's processes may not translate well to the therapeutic modalities that are coming in the next three to five years.
Biomanufacturing processes must continue to evolve to meet the demands of new therapeutic modalities, whether that entails scaling out the processing of patient specific autologous cell therapies, or quickly ramping up the production of mRNA vaccines to address the pandemic.
One solution is flexible manufacturing systems that can be built into open facilities with reconfigurable footprints and floor plans, and that can be changed to accommodate new platforms. This next generation of biomanufacturing incorporates end-to-end, fully automated and integrated processes that can be scaled up or down as needed, and that employ single-use components that lessen the need for resource-intensive cleaning and quality-control procedures.
Biopharma companies that are ready to embrace next-generation biomanufacturing can bring on partners such as the life sciences companies at Danaher Corporation to develop new, flexible processes at every stage of production, from R&D through cGMP manufacturing. The selection of flexible manufacturing products and services is growing rapidly, offering drug developers several options for optimizing the production of genomic medicines.
Meeting the demands of genomic therapy manufacturing
Biopharma giant Bayer is turning to flexible manufacturing tools that are fit for purpose as it builds its presence in the emerging field of cell therapy. In June, Bayer teamed up with Cytiva to develop the first flexible, modular manufacturing platform for allogeneic cell therapies. As both companies work to accelerate the development of cell therapies, they will leverage Bayer’s expertise in biotech manufacturing and work with Cytiva in designing the equipment solutions. Key for the joint team is creating an end-to-end solution that delivers efficiencies, establishes standards and provides economies of scale that will be applied by Bayer for its own pipeline while Cytiva makes it globally available.
The selection of flexible, integrated products and services to power next-generation biomanufacturing is growing rapidly. Cytiva can arm pharmaceutical partners with a range of manufacturing equipment, consumables and services. Backed by multiple layers of automation and digital connectivity, these solutions offer a quick path to current Good Manufacturing Practice (cGMP) success.
Flexible systems that can be installed at new or existing sites are ideal for enabling rapid scale-up of genomic manufacturing processes. For example, Cytiva’s FlexFactory™ platform is a configurable manufacturing setup that can be tailored to the available space and then adjusted as production needs evolve. The processes are completely automated, from cell culture to final vialling or from isolation to cryopreservation in the case of cell therapies.
Flexible manufacturing systems offer biopharma developers the ability to plan each step of the therapeutic development, from the bench to manufacturing, with adaptable, scalable processes that can be quickly deployed. Multiple processes can be run, including parallel batch manufacturing for personalized medicine, simultaneously, when needed, and with the FlexFactory™ platform, Cytiva can offer its expertise in process development to build a scalability plan. Cytiva pairs that process with a comprehensive supply-chain plan that ensures critical disposables, resins and other materials are available at each step. For autologous CAR-T cell therapies, a FlexFactory™ platform enables parallel batch biomanufacturing for personalized medicine.
As the manufacturing process is scaled up or scaled out, Cytiva can replicate its flexible manufacturing platform at sites around the world, offering drugmakers speed, reliability and consistency in the final product.
Additional data of single-use components
The FlexFactory™ platform is made predominantly of single-use technologies. Traditional manufacturing relies on fixed, stainless-steel equipment that has to be cleaned after each process cycle is run, and then undergo quality control before it can be reused.
Single-use systems, which include mixers, bioreactors, connectors and other components that are made from consistent materials, such as plastic, allow for easy scale-up to full cGMP manufacturing.
Pall Corporation’s Allegro™ single-use systems maintain consistent construction materials for all disposables, from cell culture through to filling processes, allowing biopharma manufacturers to feel confident they can guarantee the same robustness and reliability all the way through commercial manufacturing. And by standardizing single-use equipment and manifold designs, drug manufacturers can avoid some of the lengthy validation processes and shorten their process-development timelines.
These single-use plastics significantly reduces the need for cleaning and some of quality control required in stainless steel facilities, helping to control power and water usage. And drug developers can institute recycling or repurposing programs for plastic components.
Flexibility is the key to manufacturing success in the burgeoning genomic medicine industry. With the right partners on board, drug developers can implement fully connected manufacturing ecosystems—from equipment to project management, from testing to scale-up—that they can then quickly adapt to their changing needs.
[i] https://www.bccresearch.com/market-research/biotechnology/cell-and-gene-therapy-market.html