Donaldson Announces Integrated Lentiviral Vector Manufacturing Platform Development
Donaldson Company, Inc. (NYSE: DCI) is developing an integrated upstream and downstream platform for viral vector manufacturing, focusing on lentivirus (LV) production to improve recoveries and reduce manufacturing complexity. The platform aims to accelerate process development timelines and lower costs in the production of cell and gene therapies. Univercells Technologies and Isolere Bio are collaborating on this initiative, with Isolere's IsoTag LV affinity purification reagent offering high functional recoveries and purity, while Univercells Technologies' scale-X bioreactor demonstrates high yields of LV in perfusion mode. The project is a strategic move by Donaldson to enhance its presence in the bioprocessing space through innovative acquisitions.
Development of an integrated upstream and downstream platform for viral vector manufacturing to improve recoveries and reduce manufacturing complexity.
Promises to accelerate process development timelines and lower costs in the production of cell and gene therapies.
High yields of infectious LV demonstrated by Univercells Technologies' scale-X bioreactor in perfusion mode.
Current infectious virus recoveries are low and the virus is unstable, driving the need for improved manufacturing processes.
Challenges in achieving extended, low-shear perfusion culture, and in situ virus stabilization may require further development.
Insights
Donaldson Company's entrance into the bioprocessing space signifies a potentially transformative move for the biopharmaceutical industry, particularly in the domain of cell and gene therapy manufacturing. The integrated platform being developed targets two critical aspects: efficiency and scalability.
The use of the scale-X™ bioreactor, which is capable of achieving high yields in perfusion mode, may represent a notable advance in the cultivation of lentiviral vectors. It will be particularly interesting to monitor the yields and quality of viral vectors produced in this system compared to traditional bioreactors. Additionally, the IsoTag™ LV affinity purification reagent is intended to streamline the purification process, which could be a game-changer in terms of reducing production times and potentially lowering costs.
With biologics becoming increasingly significant in the treatment of complex diseases, the importance of efficient and scalable manufacturing processes cannot be overstated. The integration of upstream and downstream processes through this platform could set a new industry standard, provided the claimed advantages hold true during broader commercial application. The move aligns with the industry's pivot towards continuous processing, which is recognized for enhancing manufacturing robustness and product quality.
For investors, Donaldson's strategic acquisitions and the subsequent development of this manufacturing platform may reflect positively on its long-term growth potential. By targeting a growing demand within the biopharmaceutical sector, the company is positioning itself in a market that is forecasted to expand as novel therapies emerge. The claim that their platform will reduce complexity and speed up process development could give Donaldson a competitive edge if they successfully commercialize the technology.
While the company is a new player in the bioprocessing field, the ability to increase the availability of life-changing medicines could open up new revenue streams. However, the true impact on the company's financials will be contingent on the successful implementation and adoption of their platform in the market. Investors should monitor the deployment of the scale-X bioreactor in commercial product launches and subsequent market acceptance as indicators of the platform's potential success.
The emphasis on Donaldson's move to streamline viral vector manufacturing through an integrated platform could have substantial implications for cell and gene therapy markets. The technology's potential to improve recoveries and yields while maintaining a small manufacturing footprint can address some of the key challenges faced by the industry, such as production bottlenecks and high therapy costs. By focusing on lentivirus manufacturing initially, Donaldson is targeting a vector type important for certain gene therapies, thus tapping into a specific and growing market need.
The adoption rate of such innovations by Contract Development and Manufacturing Organizations (CDMOs) and other biopharmaceutical companies will be a key determinant of the success of Donaldson's platform. If the technology lives up to its promise, it could drive broader industry shifts towards more efficient production methods, potentially leading to increased access to therapies and lower costs for patients and healthcare systems alike.
The first phase of a multi vector manufacturing platform solution
“This manufacturing platform promises to establish a solution that accelerates process development timelines and reduces manufacturing complexity in the production of accessible cell and gene therapies worldwide,” said Andrew Dahlgren, Donaldson Life Sciences president.
Univercells Technologies’ scale-X™ fixed-bed bioreactor has demonstrated high yields of infectious LV in perfusion mode. Isolere’s IsoTag™ LV affinity purification reagent enables non-chromatographic purification of LV vectors with high functional recoveries, high purity, decreased unit operations and reduced total processing time. The IsoTag LV reagent confers additional stabilizing properties to the LV vectors that may be advantageous when used in conjunction with the scale-X bioreactor.
“For the first phase of the manufacturing platform, we are starting with LV given the growing demand for this vector, as current infectious virus recoveries are low and the virus is unstable,” said Kelli Luginbuhl, Isolere’s founder and general manager. “Achieving extended, low-shear perfusion culture in the scale-X bioreactor platform, together with the IsoTag LV’s in situ virus stabilization, will improve yields and lower costs.’’
Isolere’s pipeline of IsoTag reagents currently is focused on offering affinity purification solutions for adeno-associated virus (AAV), LV and positive-strand RNA viruses (ssRNA). These reagents combine tailored affinity ligands with liquid-liquid phase separation to sequester target biologics from complex solutions into large droplets. These droplets are concentrated and purified via tangential flow filtration using familiar equipment and off-the-shelf consumables.
Mathias Garny, Univercells Technologies’ general manager, said, “scale-X technology is a demonstrated bioreactor platform for rapid process development and scale-up of virus manufacturing. The design of the scale-X fixed-bed enables extended low-shear perfusion operation as well as significant reductions in host cell proteins and host cell DNA. Unlike other bioreactors, both suspension and fixed-bed, this bioreactor is directly scalable from bench to commercial-scale. It is now in use at CDMOs worldwide for clinical trial manufacturing, and the first commercial product produced in the scale-X bioreactor will launch later this year.”
“Donaldson is a new entrant into the bioprocessing space, having made selective and strategic acquisitions over the past three years,” added Dahlgren. “A key element in our strategy is to acquire innovative companies such as Isolere and Univercells Technologies that together can make a significant difference in the manufacturing of complex biologics, increasing the availability of these life-changing medicines worldwide.”
About Donaldson Company
Founded in 1915, Donaldson (NYSE: DCI) is a global leader in technology-led filtration products and solutions, serving a broad range of industries and advanced markets. Diverse, skilled employees at more than 140 locations on six continents partner with customers - from small business owners to R&D organizations and the world’s largest OEM brands. Donaldson solves complex filtration challenges through three primary segments: Mobile Solutions, Industrial Solutions and Life Sciences. Additional information is available at Donaldson.com.
About Donaldson Bioprocessing
Donaldson Bioprocessing is dedicated to advancing biopharmaceutical technologies through its subsidiaries of Isolere Bio and Univercells Technologies, among others. Isolere Bio specializes in IsoTag™ reagents and filtration processes for streamlined biopharmaceutical manufacturing, while Univercells Technologies focuses on innovative biomanufacturing solutions for cell and gene therapy research and commercial manufacturing. For more information, visit IsolereBio.com and UnivercellsTech.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508611521/en/
Sarika Dhadwal (952-887-3753)
Sarika.Dhadwal@Donaldson.com
Source: Donaldson Company, Inc.
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