Monday, August 28, 2017 Daily Archives

Particulate Contamination in Single-Use Systems: Challenges of Detection, Measurement, and Continuous Improvement

Patients receiving particulate contamination through parenteral delivery of biopharmaceuticals presents a significant potential health risk. However, the severity of that risk often is unclear. It depends on the route of administration, dosage volume administered, particle properties and amount received, and the ultimate fate of particles within a patient’s body (1). The appearance of particulate contamination also can be a visible indicator of product quality. Consequently, when such contamination is discovered within biopharmaceutical manufacturing operations, often it triggers costly investigations and…

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…