PharmaSourcesJuly 31, 2023
Tag: freeze-drying , drug delivery systems , Pharmaceutical Preparations
On 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 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.
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.
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.
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