The Singapore-based CDMO will fit out Wuhan Bio-Raid Biotechnology’s facility in China with its lentiviral vector platform and bioproduction technologies.
Esco Aster has signed a memorandum of understanding (MoU) to use its lentiviral vector platform and bioproduction technologies to support Wuhan Bio-Raid’s chimeric antigen receptor (CAR) T-cell therapy pipeline in China.
“Under the MoU, both parties have achieved a broad understanding to increase the speed of CAR-T development in China,” Esco Aster spokesperson Ai San Yip told BioProcess Insider.
This has been achieved through upstream viral vectors development and process analytics, viral titre measurement and assays, downstream process and purification, and isolators for viral packaging, storage, fill and finish.
“Esco Aster will work, hand-in-hand with Wuhan Bio-Raid to outfit their cGMP plant / tech transfer in Wuhan, China,” Yip continued, adding the facility is 3,600m2 and the project is very similar to a build-to-order model.
The deal also aids Singapore-based contract development and manufacturing organization (CDMO) Esco Aster’s strategy of expanding into the potentially lucrative Chinese market.
“China is exciting and dynamic and at the cusp of even more changes. We see vast opportunities to localise Esco’s products, Aster’s CDMO services and integrate with the Chinese way.
Esco Aster’s cell culture strategy uses adherent HEK 293T cells. Vials from a high-density cell bank are used for direct seeding into a single-use CelCradle bioreactor to generate adequate cell numbers needed for lentiviral vector production.
The CDMO’s CelCradle bioreactors are based on the concept of bellow-induced intermittent flow of media and air through porous matrices, where cells reside, which – according to the firm – provide a low shear, high aeration, and foam-free culture environment.
The technology is the only single-use packed bed bioreactor that has linear scalability from bench-scale to production scale with automated cell harvesting, the firm claims. It is also a viable alternative to scaling-out viral vector production using multilayer culture flasks of which there is currently a shortage, due to the high demand for equipment in the gene therapy space.
“Traditionally viral vectors are generated using cumbersome multi-stacked 2D vessels,” said Calista Ng, bioprocessing scientist at Esco Aster.
“Comparing them with our patented bioreactors, we have successfully shown the manufacturability of viral vectors towards a commercial scalable process adding overall advantages in terms of simple protocols, ease and relatively low cost to generate Lentiviral vectors.”