Pall Corporation Presents Approach For Speeding Vaccine Production To Shanghai Conference

East Hills, NY - As avian flu concerns extend across the globe, governments and pharmaceutical manufacturers face potentially huge demand for vaccines. According to public health experts, current production capacity and response times would not suffice in the event of a pandemic. Viral vaccine development is governed by stringent regulatory controls and can take as long as eight to 12 years costing anywhere from $300 to $800 million USD. In a presentation at the 10th annual China International Pharmaceutical Industry Exhibition in Shanghai, Ian Sellick of Pall Corporation (NYSE: PLL), described how the use of disposable and scalable technologies to purify large molecule vectors, such as for flu vaccines, can help manufacturers streamline the process and overcome many of the unique challenges associated with vaccine development.

Sellick's presentation reviewed advanced approaches to purification as part of a total process management scheme to help vaccine manufacturers address issues of scalability, validation and process development. Disposable processing systems can be installed in practically every part of the vaccine development cycle from cell fermentation and harvesting to downstream processing steps. Disposables offer lower installation costs compared to stainless steel systems and eliminate cleaning and cleaning validation. These factors significantly lower labor and maintenance costs and reduce the time required for scale-up procedures. Disposables also reduce the risk of cross-batch contamination and of worker exposure to the biohazards inherent in vaccine development.

"The use of scalable and disposable technologies can significantly improve process economics by eliminating time-consuming steps, safety risks, and several sources of capital and recurring expenses," said Sellick. "Efficient vaccine production requires flexibility and scalability, and current fears of an avian flu pandemic only increase the need for manufacturing capacity. Disposable technologies that efficiently process larger volumes can play a pivotal role in moving the majority of vaccines from clinical trial to full-scale manufacturing."

Sellick demonstrated the higher binding capacity of single-use Mustang™ membrane capsules for large molecule applications compared to conventional resin- or gel-based column chromatography. The process also incorporates the use of disposable prefilters, sterilizing grade capsules and final filters to provide exponential time, cost and labor savings. He framed Pall's total process management approach in the context of cGMP Annex 13, effective May 2004 in Europe, which specifies additional constraints for the manufacture of clinical grade products.

SOURCE: Pall Corporation