New Publication in Biotechnology and Bioengineering

Vienna, VA – In cooperation with AstraZeneca, PAK BioSolutions has published a new article in the latest issue of Biotechnology and Bioengineering. The study, titled “Fully Integrated downstream process to enable Next Generation Manufacturing,” includes data from a 14-day production run using the PAK automated system.

Information such as product quality, bioburden, and manufacturing cost savings is shared. While some benefits have been well-documented and expected, such as reduced facility footprint and protein A resin savings, it was surprising to find that product quality and purity actually increased beyond that of batch processing mode. The extremely low bioburden data has put the excessive fear of contamination in its place – the biohazard waste container.

While the automation did as expected to manage flow rate, pressure, and real-time analytical monitoring, the key programming advancement was in-line pH titration for viral inactivation. The hold time at low pH was done in-line, not in a hold container, and the addition of acid and base occurred smoothly, demonstrating a level of pH control beyond other algorithms. Don’t take my word for it – examine the beautiful data yourself.

The peer-reviewed article may be accessed here.