For biologics in the therapeutic pipeline, cell clone selection is a labor- and time-intensive component of process development.  The pressure to shorten development timelines has led to a growing use of Automated Microscale Bioreactors (AMBR) which mimics bench-scale bioreactor systems and can be used to evaluate the manufacturability of various clones in parallel.  Traditionally, cell metabolic performance and mAb titer are the primary criteria used to discriminate between clonal candidates and select the top 2-3 performers for the final round of evaluation in 5L-10L bioreactors.  Here we describe an integration of the HTPD upstream and downstream workflows to allow faster and more thorough mAb quality characterization.  The downstream workflow utilized a Tecan system which automated the removal of cells before affinity chromatography.  The purified mAb was analyzed for product quality attributes such as oligosaccharide mapping and charge heterogeneity.  The scale down HTPD downstream workflow of AMBR cultures demonstrated a comparability of mAb product qualities to those at bench-scale.  Accommodating the AMBR system with a HTPD downstream workflow allowed for an 8-fold times saving by downstream developers to generate purified mAb for product quality analysis.  Ultimately, the integration of upstream and downstream HTPD tools led to a rapid screening of clones using more relevant manufacturability criteria/attributes in the selection of final cell clone.<br/><br/>

Using HTPD to link AMBR and purification to assess manufacturability of cell line clones

255th National Meeting (2018)

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