Pharmaceutical Technology-05-15-2018
Impact of Agitator Design on Bioreactor Performance
May 15th 2018Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
Characterizing a Bioprocess with Advanced Data Analytics
May 15th 2018Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.
Ready-to-Use Parenteral Packaging Components Address Evolving Aseptic Fill/Finish Requirements
May 15th 2018Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.
Residual Moisture Testing Methods for Lyophilized Drug Products
May 15th 2018Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.
Lies That Environmental Monitoring Systems Tell
May 15th 2018Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
