Author Archives: Rene Gantier, PhD

Optimizing Continuous Monoclonal Antibody Polishing By Using Coupled Unit Operations

The biopharmaceutical industry is under a great deal of pressure to modernize manufacturing to meet the challenges of production at vastly different scales for niche drugs as well as for expected massive blockbusters, biosimilars, and regional manufacturing. To address these challenges, the biopharmaceutical industry is embracing process intensification through single-use and continuous processing technologies. Implementing these technologies offers increased productivity and manufacturing flexibility and reduces the footprint, capital outlay, and operating costs. Pall Life Sciences has developed several technologies designed…

Single-Use Technologies: BIO Theater @ Interphex 2015

Andrew Lidums (NA business development manager, Parker domnick hunter) 2:30–2:55 pm Implementing a Risk-Management–Based Approach to the Prevention of Mycoplasma Contaminations Lidums began with a recent report from Genentech, where a 150-µm long Leptospira organism from a drainage ditch outside the facility managed to penetrate 0.1-µm filters. The company solved this problem by lowering the temperature of the filtration operation, which made the bacteria more rigid and kept them from getting through. Clearly, however, contaminations happen even at large facilities.…