DEC. 12–NEW ORLEANS, La–New data demonstrating how Pall Corp.’s Mustang membrane chromatography technology speeds virus removal and improves safety of drug production were presented at the annual Parenteral Drug Association (PDA) meeting.
The technology ensures viral clearance at an extremely high throughput, which can significantly speed purification processes and accelerate the pace of new drug development. Mustang units are disposable, enabling biopharmaceutical companies to reduce manufacturing costs by eliminating cleaning and cleaning validation.
Economical production of new drugs requires innovative manufacturing processes and a shift is taking place in the industry from permanent to disposable production equipment. Disposable products eliminate the time and considerable costs associated with dismantling and cleaning equipment between batches. Pall is at the center of this growing trend with the widest range of disposable filtration and purification products on the market.
“Mustang chromatography is an innovative method of virus removal that ensures the safety of new drug products, while significantly reducing processing costs and time,” says Sam Nochumson, senior manager of Pall’s Biopurification Laboratory. “Its high dynamic capacity offers up to 100 times greater processing flow rates and eliminates cleaning validation, a huge headache for manufacturers.” Mustang chromatography can potentially save manufacturers up to 200 days of process development time.
Nochumson presented data demonstrating how Mustang ion exchange technology removes an array of viruses through charged membranes. In performance tests, over 7 logs of Porcine Parvovirus (PRV) were removed in one processing pass, a significant technical achievement. There were also dramatic log reductions for a range of other pathogens, including retroviruses (HIV and Murine Leukemia Virus), Hepatitis A (HAV), and Pseudorabies (PRV). These test organisms represent the variety of large and small, enveloped and nonenveloped viruses, which can destroy production runs that may be valued at several thousand dollars per milligram.
“Traditional chromatography has limited application for large-scale viral clearance because of its relatively low capacity, and long residence times,” says Tim N. Warner, senior manager of process development and biopurification at Pall. “Employing membrane ion exchange technology, Mustang chromatography offers manufacturers a viable new method of high throughput viral clearance that is disposable and extremely convenient for scaling up.”