The September issue Production theme includes articles on deviation management, product lifecycle management, trends in China’s biopharmaceutical industry, “unican” single-use bioreactors, risks of polysorbates in formulations, and using single-use minibioreactors for plasmid DNA process development.
FEATURED REPORT: The BPI Theater @ BIO 2017
The 2017 BPI Theater @ BIO took place June 20-22 in San Diego CA and focused on two main themes: emerging therapies and emerging technologies. The BPI Theater provides convention attendees working and interested in biopharmaceutical research, development and manufacturing with a dedicated destination to meet, network, and experience the latest science and technology trends impacting bioprocessing. Summaries of the presentations were included in the July-August Featured Report, and full video presentations are available for on-demand viewing.
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…