During production of therapeutic antibodies, harvest titer is measured to monitor product mass loaded onto the protein A capture column. This prevents both column underloading (underusing expensive resin) and overloading (wasting product as flow-through (FT)) while allowing for column yield calculations. Batch production yields a single homogenous harvest pool, thus only one titer measurement (along with volume loaded) is sufficient to determine the mass loaded. During continuous production, however, cell-free harvest (permeate) continuously exits a perfusion reactor and loads a…
Author Archives: Anoushka Durve
High-Throughput Methods Evaluation: Impurities Determination During Upstream and Downstream In-Process Development
Getting biologic drugs through development and into clinical proof-of-concept studies quickly and efficiently is critical for success in the biopharmaceutical industry. Implementing high-throughput approaches to both upstream and downstream process development is increasingly helping companies stay competitive. Innovative and highthroughput analytical technologies are needed to support rapid process development. The study reported herein focuses on innovative immunoassay platforms for impurity-removal monitoring of both host-cell proteins (HCPs) and leached protein A. HCPs come from host cells during cell culture production. Their…