The primary article you are looking for is titled "A-Mab: A Case Study in Bioprocess Development," published on October 30, 2009, by the CMC Biotech Working Group International Society for Pharmaceutical Engineering (ISPE)
Protein A capacity remains stable at 40 g/L resin. Elution at pH 3.5 yields 95% purity with <0.1% aggregates. However, the low-pH elution creates a new problem: inactivation of a small fraction of Mab-X, reducing potency by 10%. A Mab A Case Study In Bioprocess Development
High turbidity in the load causes column fouling and pressure spikes >3 bar. The primary article you are looking for is
: Determining Critical Quality Attributes (CQAs) —such as glycosylation, aggregation, and host cell protein (HCP) levels—that must be controlled to ensure drug performance. Main peak 73%, acidic 15%, basic 12%
The production process included a dedicated after elution.
Based on characterization data, a is established. This is the multidimensional combination of input variables (e.g., temperature, pH) and process parameters that have been demonstrated to provide assurance of quality.