Monday, August 28, 2017 Daily Archives

Proper Task Performance in GMP BioManufacturing: Human Error Reductions

This webcast features: Tony Fultz, Director of Upstream Manufacturing at Fujifilm Diosynth Biotechnologies. Human error reduction should be a top priority of every organization. Our company, clients, and most importantly, our patients are heavily dependent on right first time execution. Human error is, and will likely always be, the highest contributor to deviations and batch failures. Fujifilm Diosynth Biotechnology (FDB) is aggressively seeking to reduce human error. Using his experience in the nuclear industry, Tony Fultz shares a method implemented…

Three’s Company: Formulation Prep and Stability Screening With Grunt, Lunatic and Uncle

The stability of biologics can be highly dependent on formulation pH. The pH can be screened by buffer exchanging proteins into a variety of buffer salts and running follow-up analytics to determine stability. Current practices for buffer exchange all have limitations. Dialysis requires a large excess of buffer and time. Centrifugal filters and desalting columns are faster, but require more hands-on time. Additionally, all three methods require dilution or concentration steps to reach target protein concentrations. Automating buffer exchange eliminates…