Ghent University scientists launch CEPI-funded project ‘spin-freezing’ vaccines

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New ‘spin freezing’ technique could enhance future mRNA vaccines.

11 March 2024, OSLO, Norway and GHENT, Belgium – A top-ranking public research university in Belgium has received funding from CEPI to explore whether a pioneering vaccine stabilisation technique could end the need for frozen storage of mRNA vaccines and support a fast and scaled-up response to future outbreaks in as little as 100 days.

Ghent University will receive up to US $1.9 million to test the performance of optimised mRNA vaccines, developed on the university’s specialised mRNA Galsomes platform, in preclinical models after ‘spin-freezing’ the vaccines. Pioneered by RheaVita, a spin-off company of Ghent University, spin-freezing is a novel alternative to the traditional freeze-drying method. The research will be supported by Flanders Institute for Biotechnology (VIB).

Spin-freezing: the next vaccine-drying frontier?
In freeze-drying, certain types of vaccines and other products including diagnostics, therapeutics as well as certain foods, are dehydrated and temporarily stored as a powder at heat-stable temperatures to inhibit spoilage, extend shelf life and increase access to these products in remote or low-resource settings (as the products no longer require frozen storage).

The new technique, spin-freezing, could offer additional benefits to the traditional freeze-drying method and therefore has the potential to become a preferred technique for vaccine makers.

Spin-freezing works by rapidly rotating vials of vaccine along an axis while the flow of an inert and cold gas solidifies the vaccine into a thin powder film around the side of the vial. This allows for a much faster drying process and offers manufacturers more control of the process, which can help improve the quality of vaccines being produced.

Vaccine producers can also spin-freeze vaccines continuously, vial by vial, thereby reducing expensive and time-consuming bottlenecks and delays that can commonly occur during traditional freeze-drying where vaccines are manufactured in batches. While batch manufacturing has long been the industry standard, continuous manufacturing could offer improved efficiency, with raw materials constantly fed into the production line and collected at the end which could help bring vaccines to market more quickly. It could also reduce labour and waste to help with cost savings.

Altogether, these potential benefits could push forward the 100 Days Mission, a goal spearheaded by CEPI and embraced by the G7 and G20, to accelerate vaccine development to around 100 days from identification of a future virus and stop an outbreak before it becomes a pandemic.

“Innovators are increasingly looking to meet the challenge of rapidly scaling up of thermostable mRNA vaccine doses for wider global delivery” explains Ingrid Kromann, Acting Executive Director of Vaccine Manufacturing and Supply Chain at CEPI. “In addition to making mRNA vaccines thermostable, spin-freezing has the potential to flip the usual batch production process utilised by pharmaceutical manufacturers and instead offer continuous manufacturing, which, if successful, could promote fast and flexible mRNA vaccine production in response to future outbreaks.”

Dr. Ine Lentacker and Prof. Thomas De Beer, Ghent University, said: “We are currently validating our mRNA vaccine platform, mRNA Galsomes, as a prophylactic vaccine against various infectious diseases. Leveraging the innovative continuous freeze-drying technology and expertise in biomolecule production and analytics at Ghent University, we are excited that this collaboration between Ghent University and CEPI provides us with a great opportunity to improve the thermostability of mRNA Galsomes. We believe that our efforts to address challenges posed by cold chain distribution could significantly contribute to equitable access to mRNA vaccines globally.”

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Coriolis Pharma and RheaVita join forces in collaboration for continuous and controlled freeze-drying technology

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_Coriolis Pharma extends its service portfolio by integrating RheaVita’s single vial unit (SVU) technology for continuous and controlled freeze-drying to stabilize novel modalities as part of biologics drug product development for clients.

Martinsried-Munich, Germany, July 31, 2023 – Coriolis Pharma, a globally operating service provider and one of the world leaders in formulation research and development of biopharmaceutical drugs, and RheaVita, a pioneer and supplier of continuous freeze-drying technology for biopharmaceutical products, today announced their collaboration to pave the path of the novel technology for drug product development of biologics, in particular novel modalities.

RheaVita’s patented continuous freeze-drying technology integrates all traditional freeze-drying steps into a continuous production line. This enables pharmaceutical companies to achieve rapid product and process development, as well as highly flexible and efficient production cycles with 100% controlled product quality. The technology enables both high-volume centralized manufacturing and low-volume, high-value decentralized manufacturing, making it ideal for innovative biologic therapies such as gene therapy, RNA-based therapies, antibodies, vaccines, as well as precision medicine and orphan drug manufacturing.

Coriolis will offer the SVU technology alongside with other technologies and methods for its client formulation development projects. Coriolis remains committed to provide technology-independent advice to realize customized studies with pure focus on providing the optimum solution for the the individual drug product. Clients will benefit from Coriolis’ long-term expertise in formulation development, lyophilization and analytics for a wide range of molecule classes, which is brought to bear in the evaluation of the SVU technology.

“RheaVita’s SVU technology is the ideal supplement for our existing methods in the field of lyophilization process development”, commented Dr. Michael Wiggenhorn, founder and board director at Coriolis Pharma. “Through our service model, our clients will get the chance to test and evaluate the new technology by a formulation development expert for their own drug development strategy.“

RheaVita already sells its technology (SVU and GMP-Flex equipment) and know-how in the field of continuous and controlled freeze drying to a large number of clients in the pharmaceutical industry, worldwide. Within the framework of this collaboration, RheaVita will benefit from Coriolis as a multiplier to enable the validation of the technology  for different types of drug products and a wider range of applications. In the long run, the scientific exchange between the two companies will allow the technology to be extended to new molecule classes.

“Coriolis’ extensive scientific expertise with various molecule categories and their deep expertise in formulation development have convinced us, that we have found the ideal partner to expand the accessibility of our technology  to a broader audience in the future,” said Dr. Thomas De Beer, CEO at RheaVita.

During the upcoming Freeze-Drying of Pharmaceuticals & Biologics conference from August 1 to August 4, 2023 in Breckenridge, Colorado, USA, both companies will showcase and scientifically present the technology alongside other advancements in lyophilization development.

About Coriolis Pharma

Coriolis Pharma is a globally operating contract research organization, and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs, including cell and gene therapy products and vaccines. The company’s offering includes early and late-stage formulation development for liquid and lyophilized drug products, lyophilization process development and analytical development under R&D and GMP. Non-GMP manufacturing services for a wide range of products complete the service portfolio.

It is the vision of Coriolis to revolutionize the development process of biopharmaceutical drugs by integrating innovative digital formulation approaches from drug development to commercial products. Coriolis Pharma thereby enables future therapies to be made available to humankind efficiently and on time.

With its interdisciplinary team of highly skilled scientists and an expert scientific advisory board, Coriolis provides QbD-compatible cutting-edge development services and tailor-made solutions for its clients. Founded in 2008 and headquartered in Martinsried near Munich, Germany, Coriolis currently employs around 200 employees from over 36 nations around the world. For more information visit https://www.coriolis-pharma.com.

About RheaVita

RheaVita has developed a continuous, controlled freeze-drying technology that integrates all the traditional freeze-drying process steps into one continuous production line. By spinning the glass vials during the freezing process, a thin layer of product coats the inner lining of the vial. Following drying, the final solid freeze-dried product is obtained. Compared to the traditional freeze-drying process, RheaVita’s approach has several advantages, including very fast product and process development with limited experimental efforts, avoiding scale-up issues, reducing cycle times, lower production costs, less clean room space requirements, improving quality assurance and improved and uniform product quality and process uniformity. The design process was accompanied by the development of a digital twin, a ‘virtual reality’ version of the system to facilitate future process development and optimization, assist with maintenance and repair as well as training of operators. RheaVita was founded in 2018 as a spin-out of Ghent University. For more information visit https://www.rheavita.com.

Press Contacts:

Bettina von Klitzing-Stückle
Scientific Marketing Manager
Coriolis Pharma Research GmbH
+49 (0) 89 4177 60 – 0
bettina.klitzing@coriolis-pharma.com
www.coriolis-pharma.com

Pieter-Jan Van Bockstal
Scientific Communication
RheaVita
+32(0)496498322
info@rheavita.com
www.rheavita.com

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RheaVita Closes EUR 2.5 million Series A Financing Co-Led by Novalis Biotech Acceleration and PMV

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Proceeds will be used to build first GMP compliant biopharmaceutical continuous, controlled, freeze-drying production line and accelerate commercialization of the RheaVita technology.

 

First GMP compliant manufacturing line scheduled to go live by end of 2021.

Ghent, Belgium, June 2, 2021 – RheaVita, a company pioneering continuous freeze-drying technology for biopharmaceutical products, announced today that the company has closed a EUR 2.5 million Series A Financing. The round was co-led by Novalis Biotech Acceleration and Participatie Maatschappij Vlaanderen (PMV). Concurrent with the financing, Kjell Mortier from Novalis Biotech Acceleration and Stefan De Waele of PMV will join RheaVita’s Board of Directors.

Today, almost 50% of FDA and EMA approved biopharmaceutical products are freeze-dried to enable stable product distribution and shelf life without the need for expensive cold chain. RheaVita has developed the world’s first end-to-end continuous freeze-drying solution to address biopharmaceutical product development, manufacturing and supply needs in order to efficiently reach patients. The patented RheaVita continuous freeze-drying technology integrates all the traditional freeze-drying process steps into one continuous production line. This allows pharmaceutical companies to achieve rapid product and process development, and highly flexible and efficient manufacturing cycles with 100% controlled product quality. The technology enables both centralized large volume and decentralized low-volume-high-value product manufacturing and so is also ideally suited for innovative biological therapies, such as gene therapy, RNA based therapies, antibodies, vaccines, and to produce precision medicines and drug products for rare diseases. RheaVita will use the proceeds to further develop and accelerate commercialization of its innovative R&D and GMP compliant continuous freeze-drying production-scale equipment, along with the concomitant team expansion. In addition, RheaVita will continue to offer product feasibility studies and provide customers product and process development support using its continuous freeze-drying technology.

“RheaVita has developed a game-changing technology for the fast-growing biopharmaceutical sector, so fits perfectly into the remit of our Acceleration fund,” said Kjell Mortier, Fund Manager at Novalis Biotech. “We were impressed by the experience of the team, and the strong commercial interest from pharma and biotech companies in their technology. RheaVita is uniquely placed to disrupt the freeze-drying market as their technology offers a perfect solution to the challenges faced with the conventional approach. We look forward to working with the RheaVita team as they provide their innovative solution to the pharmaceutical industry.”

“The increasing interest from the pharmaceutical industry into alternatives for conventional freeze drying creates a unique opportunity for RheaVita”, said Roald Borré, Group Manager Venture Capital at PMV. “Support from PMV should allow management to further develop their ground-breaking technology in Flanders and commercialize worldwide.”

“This financing will enable RheaVita to realise a major step in our corporate development; the installation of the first GMP compliant production line for our innovative continuous freeze-drying technology. We believe this will provide a fast and flexible development and manufacturing solution to accelerate supply of tomorrow’s biopharmaceuticals,” said Jos Cover, co-founder and CTO of RheaVita.

“With the proceeds, we will also be able to deliver on our corporate growth plan, build our team accordingly and further expand the commercialization of our technology,” added Prof. Dr. Thomas De Beer, co-founder and CEO of RheaVita. “We’d like to thank Novalis and PMV for their faith in our vision and look forward to working closely with Kjell and Stefan to implement our strategy.”

About Novalis Biotech Acceleration
Novalis Biotech (Ghent, Belgium) is an early-stage venture capital investor in technologies that revolutionize healthcare. The company’s core competence lies in digitalization in the life sciences with a focus on “enabling technologies” such as bioinformatics, genomics and diagnostics. Novalis strongly believes in applying innovative enabling technology to advance the prevention, diagnosis, or treatment of a disease.

For more information, please visit www.noval.is.

About PMV
PMV is a Flemish investment company that finances promising companies from the very start to growth and internationalization. PMV offers tailor-made financial solutions for every entrepreneur with a solid business plan and a strong management team, by providing venture capital, loans and guarantees. An experienced and highly motivated team of 150 professionals endeavors every day to achieve the goal of creating prosperity and well-being in Flanders. PMV has a portfolio of about EUR 1.3 billion in assets under management.  More info about PMV can be found on www.pmv.eu.

About RheaVita
RheaVita has developed a continuous, controlled freeze-drying technology that integrates all the traditional freeze-drying process steps into one continuous production line. By spinning the glass vials during the freezing process, a thin layer of product coats the inner lining of the vial. Following drying, the final solid freeze-dried product is obtained. Compared to the traditional freeze-drying process, RheaVita’s approach has several advantages, including very fast product and process development with limited experimental efforts, avoiding scale-up issues, reducing cycle times, lower production costs, less clean room space requirements, improving quality assurance and improved and uniform product quality and process uniformity. The design process was accompanied by the development of a digital twin, a ‘virtual reality’ version of the system to facilitate future process development and optimization, assist with maintenance and repair as well as training of operators. RheaVita was founded in 2018 as a spin-out of Ghent University.

For more information, please visit www.rheavita.com.

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