Vivaspin Turbo 15: A New Generation Of Ultrafiltration
The disposable Vivaspin Turbo 15 is optimally suited for protein, virus or nanoparticle concentration, as well as desalting, dialysis and buffer exchange. It can handle up to a 15 ml sample volume in swing bucket rotors and 11ml in fixed angle rotors accepting 50 ml centrifuge tubes. Vivaspin® Turbo 15 ensures maximum process speeds right down to the last few microliters after > 100 fold concentration. Learn more.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
What serialization deadlines should the pharma industry be preparing for? Because federal legislation would trump California law, these are the questions everyone is asking. And until the Senate passes a track-and-trace bill, it will continue to be a waiting game.
By Annette Kaya, Process Engineer Process Design and Simulation; Andrea Uebele, Engineer in Process Technology; Anke Seeger, Head of Section Facility Design and Simulation; M+W Process Industries, et al.
Contract manufacturer DSM Biologics, at its current good manufacturing practices (CGMP) facility in Groningen, The Netherlands, provides services for clinical development and commercial production based on mammalian cell culture technology.
By Tim Russell, TSI Incorporated
A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors, such as optical particle counters, differential pressure sensors, and temperature probes, in real time.
By Oliver Stauffer, PTI Packaging and Inspection Systems
Oliver Stauffer of PTI Inspection Systems gave a presentation on "Nondestructive Package Testing: Driving Sustainable Operations" during the Pharmapack North American Conference and Exposition, in Philadelphia, PA. Stauffer, vice president of inspection technologies for PTI, reviewed the Six Sigma DMAIC framework and how it directly applies to developing a strategy and test methodology for package integrity.
By Lei Li, Eli Lilly and Company
Utilization of prefilled syringes as a preferred container closure system for biologics has been increasing. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity. In 2008, the FDA further promoted container and closure system integrity (CCI) testing as a component of the stability protocol for sterile products.