As programs move from development to the clinic, it is imperative to establish a data package around each of the upstream, downstream, and supporting analytical testing needs to reproducibly manufacture a protein of interest.
TIA Facilities offer access to a full spectrum of industrially relevant capabilities to develop and optimise upstream and downstream manufacturing processes. Single-use product-contact surfaces help mitigate the risk of cross-contamination and improves efficiency, with scaling options from bench up to 200 L.
We develop and tailor purification strategies to ensure that the end product is stable, fit for purpose and meets purity and safety requirements, from simple affinity-tagged research-enabling milligram protein preparations to gram quantities from Phase I-enabling bioprocesses. Process development is supported by state-of-the-art bioanalytics and method development expertise to build a data packages around thermal stability and assessing protein quantity, purity, and quality.