Esco Aster is the global leader in providing process transfer services to meet scale up needs of the industry. The Tide Motion® Bioreactor platform is a viable and robust solution to replace adherent cell culture systems such as 2D planar cultures, roller bottles and 3D microcarriers that are widely used to produce Phase III and commercial drug products.
Many commercial biologics utilize cells such as adherent CHO for production of Eythropoietin (EPO), Ipilimumab, Interferon beta-1a and others; human and animal vaccines as well are produced using roller bottles. Tide Motion® Bioreactors mimic the rolling motion of Roller bottles which is an alternate emerging and submerging of cells for oxygenation and nutrient exchange.
By virtue of this, we offer a viable alternative to Roller bottle culture. This could be a less expensive and time –consuming as opposed to bioengineering adherent cell lines to suspension cells which may entail redoing of large-scale clinical trials and subsequent issues from a regulatory standpoint.
The other very important application of Tide Motion® Bioreactors is in stem cell culture. Existing commercial and late stage allogeneic mesenchymal stem cell or mesenchymal stromal or medicinal signaling cells are often manufactured using either 2D multilayer planar culture ware with optional automated harvesting or 3D microcarriers which are occasionally dissolvable but often not.
Esco Aster provides Tide Motion® method as an alternative to linearly aid in scaling up MSCs for allogeneic cell therapy. The Tide Motion platform can also be used to produce allogeneic cell sources for gene- edited cell therapy as such CAR-T, CAR-NK as well as other immune cells that are derived from iPSCs or hESCs. Thus, other adherent packed bed bioreactors, hyperflasks, hyperstacks can easily be replaced by the Tide Motion® platform to provide viral vectors, for gene therapy and oncolytic viruses or cancer vaccines which often utilize HEK 293T and other adherent cell lines as expression platforms.
Our CelCradle™ X provides an alternative to other packed-bed bioreactors used for adherent autologous cell therapy ranging from Hollow Fiber bioreactors to automated multilayer culture bioreactors.
In addition to bioprocessing solutions, our analytical services utilizing analytical high performance liquid chromatography (HPLC), sodium dodecyl sulphate–polyacrylamide gel electrophoresis (SDS-PAGE) and other analytical tools ensure that the Drug Substance and Drug Product are compatible and thus ensures equivalency. Other in vitro and in vivo techniques such as binding affinity utilizing Attana and BioCore are also utilized.
Our clinical trial and commercial sites are able to produce Drug Products for bridging studies in a variety of container formats with our own quality control and lot release including sterility and stability testing.