This Month’s Issue
The BioProcess International April 2016 production theme issue cover is illustrated by TAP Biosystems microscale bioreactors from Sartorius Stedim Biotech. (www.tapbiosystems.com)
For the cell and gene therapy business, learning from the failures and successes of the protein-based markets’ journey to commercial success provides a treasure-trove of knowledge and experience that can and should be followed in order to use and reproduce what worked, while steering clear of what didn’t. One clear lesson is clear: in order for the cell and gene therapy industry to complete the bridge to commercial success, technology must catch up to the science.
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…