It outlines a systematic approach to identifying which product attributes (like glycosylation or aggregation) significantly impact safety and efficacy. Upstream Manufacturing Development:
Out of 500 clones screened, Clone 17B shows the highest specific productivity (qP = 25 pg/cell/day). However, early batch cultures reveal a problematic metabolite profile: high lactate accumulation (4 g/L) and ammonia (2 mM). High lactate inhibits cell growth and reduces final titers.
Commercially available ELISA kits quantified residual HCP (
The depth filters for the Protein A load are undersized by linear scale-up (based on volume). A more accurate scale-up factor——shows that the large-scale filter needs 2.5x more area than calculated. After revision, all filter capacity tests pass.
Fine depth filter to remove sub-micron particles and colloidal matter.
It outlines a systematic approach to identifying which product attributes (like glycosylation or aggregation) significantly impact safety and efficacy. Upstream Manufacturing Development:
Out of 500 clones screened, Clone 17B shows the highest specific productivity (qP = 25 pg/cell/day). However, early batch cultures reveal a problematic metabolite profile: high lactate accumulation (4 g/L) and ammonia (2 mM). High lactate inhibits cell growth and reduces final titers. A Mab A Case Study In Bioprocess Development
Commercially available ELISA kits quantified residual HCP ( It outlines a systematic approach to identifying which
The depth filters for the Protein A load are undersized by linear scale-up (based on volume). A more accurate scale-up factor——shows that the large-scale filter needs 2.5x more area than calculated. After revision, all filter capacity tests pass. High lactate inhibits cell growth and reduces final titers
Fine depth filter to remove sub-micron particles and colloidal matter.