Recombinant proteins have become critical for our growing global populations' health and wellness.In addition to being used as therapies and vaccines, recombinant proteins are used as reagents in the manufacturing of other biol. treatments, including cell and gene therapies, as diagnostics, and even in alternative foods and synthetic fibers.Conventional methods for manufacturing recombinant proteins are limited, however, because they require significant know-how, capital investment, and specialized space.Our goal at Sunflower Therapeutics is to democratize protein manufacturing by providing easy-to-use, automated, small-footprint manufacturing solutionsWe initially set out to demonstrate and commercialize end-to-end, fully integrated systems for protein manufacturing called the DahliaTM and DaisyTM systems, which include modules for perfusion fermentation, straight-through chromatog., tangential flow filtration, and refrigerated collection.During the development and demonstration of the smaller volumetric scale DaisyTM end-to-end system, we realized that the module for perfusion fermentation was particularly unique and didn't exist anywhere else as a com. offering.While process development for chromatog. and tangential flow filtration methods deployed on our systems could be performed on com. available equipment, there is no other equipment capable of perfusion fermentation for eukaryotic microbes currently.Recognizing this gap in the market, we developed a stand-alone bioreactor system designed specifically for perfusion fermentation, called the Daisy PetalTM .Here, we show the broad benefits of the Daisy PetalTM through both our own demonstrations and data collected from early access customers.Using continuous operation, the Daisy PetalTM allows users to test key process parameters more efficiently, collect meaningful data faster in one campaign, or just make more cells and/or protein than in typical fed-batch fermentationIn addition to scientific advancement, we prioritized development of a system that would improve accessibility and lower comparative cost of ownership.The system empowers non-expert users to get started quickly, with fully automated operations and simple installation of single-use consumables.Early access users, including students with no prior bioprocess experience, said "The Daisy Petal is really simple to use.I knew exactly how to get started."

Perfusion fermentation of eukaryotic microbes enables increased productivity, sustainability and accessibility

Author: Crowell, Laura E. ; Love, Kerry ; Bonnyman, Alexandra

Perfusion is a mode of continuous cultivation where cells are retained in a bioreactor while cultivation fluid is constantly added and spent media (usually containing a secreted protein product) is continuously removed.The benefits of perfusion cultivation have been well demonstrated using mammalian cells and include a reduced manufacturing footprint, lower capital investment and ongoing operational costs, and increased flexibility, productivity and product quality.The application of perfusion techniques to the cultivation of eukaryotic microbes, however, has been limited to date.The most prevalent method of perfusion requires removing the cells from the bioreactor, separating the cells from the spent media, and then returning the cells to the bioreactor.This is not a viable solution for cell types with high growth and respiration rates, like eukaryotic microbes, because the cells spend too much time outside of the controlled environment of the bioreactor, which limits viability and productivity.Here, we describe a method of perfusion that is suitable for eukaryotic microbes utilizing an in-vessel cell retention device (CRD).Sunflower's proprietary CRD allows for the continuous removal of spent media without the cells ever leaving the controlled bioreactor environment.Using this unique cell retention device, we have developed a single-use bench-top bioreactor for automated, continuous production of proteins from eukaryotic microbes-the Daisy PetalTM .We show that the Daisy PetalTM can be used for efficient continuous production of a variety of recombinant proteins by the yeast Pichia pastoris, including cytokines and hormones, subunit vaccines, monoclonal antibodies and other antibody-like products.Using perfusion fermentation, processes can run at least twice as long as compared to fed-batch, while maintaining high cell densities (over 500 wet cell weight).Furthermore, we demonstrate how perfusion fermentation can be used to simplify process optimization by testing multiple process conditions in a single campaign.

Democratization of protein-based drug and vaccine supply through regional small-footprint manufacturing

Author: Crowell, Laura E. ; Bonnyman, Alexandra

Local biomanufg. capacity could transform access to therapeutics in low- and middle-income countries (LMICs) by promoting self-sufficiency to address current and future needs for biol. drugs and vaccines, ultimately improving both regional livelihoods and health outcomes.Small-footprint approaches to biomanufg. are particularly relevant for deployment in LMICs, given the lower up-front capital and phys. space needed for their deployment as compared to large-scale legacy manufacturing facilities.At Sunflower Therapeutics, we have developed integrated, continuous, and automated small-footprint (<50 m) manufacturing technologies for the production of pharmaceutical-quality proteins using eukaryotic microbes.Our unique systems allow non-experts to get started making diverse proteins fast using fully automated hardware and intuitive single-use consumables with significantly reduced capital expenditures and simpler space compared to conventional facility designs.Sunflower equipment is also capable of multi-product manufacturing, which could provide the flexibility required for the diverse needs of low- and middle-income countries (LMICs) and support the development of a portfolio of products for a given regional business.Here, we will describe Sunflower's on-going efforts to identify and de-risk a variety of protein products that can be deployed cost-effectively in-market using our manufacturing approach.Products across a variety of protein classes are considered, including antibodies and antibody-like products, subunit vaccine antigens, virus-like particles, cytokines, hormones, small binding proteins and more.Through case studies, we demonstrate the benefits and flexibility of our multi-product manufacturing approach, both in terms of using an alternative host (Pichia pastoris) for the production of high-quality proteins and in the deployment of processes in Sunflower's automated, small-footprint manufacturing systems.

News (Medical) associated with Sunflower Therapeutics, PBC

24 Jul 2024

·www.businesswire.com

Sunflower Therapeutics Announces SK bioscience’s $2M SAFE Investment

MEDFORD, Mass. & SEONGNAM, South Korea--([BUSINESS WIRE](https://www.businesswire.com/))--[Sunflower Therapeutics](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fsunflowertx.com%2F&esheet=54099346&newsitemid=20240725394078&lan=en-US&anchor=Sunflower+Therapeutics&index=1&md5=5d5fb957eafe7c02d402440b16afd511), a public benefit corporation transforming global access to protein manufacturing capacity for diverse applications, today announced that [SK bioscience](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.skbioscience.com%2Fen%2Fmain&esheet=54099346&newsitemid=20240725394078&lan=en-US&anchor=SK+bioscience&index=2&md5=aca64aa9e3237f3d5bceb447e73080d2), a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, has participated in Sunflower’s simple agreement for future equity (SAFE), a flexible agreement providing future equity rights without immediate valuation, with a $2M subscription to solidify their support for the companies’ ongoing research and development R&D collaborations. The subscription builds on Sunflower and SK bioscience’s existing collaboration to develop an efficient manufacturing process for an accessible human papillomavirus (HPV) vaccine using the alternative protein expression host _Pichia pastoris_. Through their partnership, SK bioscience is leveraging Sunflower’s expertise in the development of integrated biomanufacturing processes using alternative hosts in the development and manufacturing of accessible, clinically relevant vaccines for combatting public health crises such as HPV and cervical cancer. “In this time where various infectious diseases threaten humanity, vaccine sovereignty is the key to protecting the safety of our people and enhancing national competition,” said Jaeyong Ahn, CEO of SK bioscience. “We are excited to deepen our relationship with Sunflower Therapeutics and make an impact on global health as we continue to develop efficacious, safe and cost-effective vaccines.” Sunflower’s cutting-edge approach uses continuous fermentation, an entirely new way to make virus-like particles (VLPs) and has been proven to be five to ten times more effective in space-time yields for VLPs than fed-batch fermentation. Through the companies’ collaboration, Sunflower is evaluating the potential for cost-effective manufacturing in _P. pastoris_ using Sunflower’s Daisy PetalTM perfusion bioreactor system, a laboratory-scale, automated manufacturing system for the integrated production of purified protein bulk using microbes. “Our accessible, cutting-edge protein manufacturing solutions are moving the needle by reimagining the biologic development process,” said Dr. Kerry R. Love, Founder, CEO and President of Sunflower Therapeutics. “We’re thrilled by SK bioscience’s expanded support and look forward to democratizing and supporting product development for vaccine producers across the globe with our next-generation manufacturing technologies, coupled with our thoughtful, resourceful services.” To learn more, please visit [sunflowertx.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fsunflowertx.com&esheet=54099346&newsitemid=20240725394078&lan=en-US&anchor=sunflowertx.com&index=3&md5=dd81bf5aaf58b7621f38222f845379d2).

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