To achieve quality by design in biopharmaceutical production, manufacturers need tools that can ensure the stability of critical process parameters (CPPs) and other performance indicators related to product critical quality attributes (CQAs). Over the past couple of decades, sophisticated process analytical technologies (PATs) have emerged to address such needs. Offerings are now abounding for single-purpose sensors that measure temperature, pressure, pH, glucose, protein concentration, or dissolved oxygen. New in-line formats are enabling such instruments to provide data in real time,…
Author Archives: Mason A. Chilmonczyk
Improving Cell Manufacturing Outcomes Using In-Line Biomarker Monitoring
Cell-based advanced therapies are changing modern medicine dramatically. Immunotherapies such as chimeric antigen receptor (CAR) T-cell therapies are treating different forms of cancer. Gene therapies are reversing the course of inherited diseases, and tissue-engineered medical products are restoring, maintaining, and replacing damaged organs (1–4). The development of new advanced therapies is booming. As of January 2020, the US Food and Drug Administration (FDA) has reported more than 900 investigational new drug (IND) applications for cell and gene therapy products. However,…