Univercells has launched a contract development and manufacturing organisation (CDMO), Exothera, to support cell and gene therapy developers with process development and production of viral vectors.
The new company has been created to help alleviate the two most critical challenges manufacturers face in bringing these vital therapies to market: a structural lack of capacity and scarcity of bioprocessing expertise.
Exothera is positioned to create bespoke bioproduction support programmes for manufacturers to achieve successful market entry. The team combines complex applied bioprocessing experience with best-in-class technologies.
Existing infrastructure will be revamped to accommodate state-of-the-art labs, cleanrooms, and GMP qualified manufacturing
Parent company Univercells’ novel manufacturing platforms will be leveraged among others, to design high-quality, cost-effective viral vector processes with the option of implementing sustainable commercial facilities at the customer site if desired.
By taking a holistic approach to rapidly deliver scalable bioproduction processes, the CDMO will help cell and gene therapy innovators accelerate the delivery of these groundbreaking therapies with drastic reductions in time to market and cost.
Location location location
Following initial activities in the established facilities in Gosselies and Nivelles, Exothera’s capabilities will be housed at a 15,000 sqm site in Jumet, Belgium, recently acquired by Univercells. The existing infrastructure of the Jumet site will be revamped to accommodate state-of-the-art laboratories, cleanrooms, and GMP qualified manufacturing areas for clinical and commercial production.
Exothera Jumet site
Capacity ramp-up will rapidly foster local employment, with an extensive hiring effort to appoint PhD scientists, manufacturing experts and laboratories technicians.
The flexible GMP areas at Jumet will contain Exothera’s CDMO activities and ongoing Univercells vaccine development and manufacturing initiatives, with capacity for rapid response programmes.
COVID-19
On the rapid response front, the company is currently pursuing support opportunities for COVID-19 vaccine innovators, drawing on vast capability and know-how in expediting successful vaccine manufacturing programmes.
“This new focus will enable our team to leverage expertise with innovation to overcome the industry’s production constraints and foster the success of cell and gene therapies”, declared Hugues Bultot, CEO of Univercells and Exothera.“We strongly believe that Exothera will make a difference in the manufacturing of these advanced and critically needed therapies, ultimately unlocking their potential to improve patients’ lives.”