Process Development and Characterisation
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 the protein of interest.
Single-use product-contact surfaces helps mitigate the risk of cross-contaminations and to drive efficiencies within NBF operations. The full range of process scales is covered with single-use options from bench up to 200 L bioreactor scale. The NBF also utilises single-use flow paths for clinical production with single-use Akta ready chromatography skids as well as automated single-use TFF and VF skids.
The NBF tailors their number of purification steps and required downstream development strategy to ensure the end product is stable, fit for purpose and meets your purity profile requirements. From simple affinity-tagged research-enabling milligram protein preparations through to gram quantities from Phase I-enabling bioprocesses that meet viral clearance and exacting Certificate of Analysis release packages.
Industrially Relevant Purification Strategies
Upstream development focuses on optimising the process with a clinical or Good Manufacturing Practice (GMP) manufacturing in mind, utilising initial range-finding 250 mL Ambr microbioreactor systems through to process confirmation in 10, 50 and 200L single-use bioreactors
Upstream Development: Fed Batch and Perfusion
The NBF has state-of-the-art laboratory analysis equipment, coupled with proven analytical method development expertise to build the data package assessing protein quantity, purity, quality, and stability.