In a presentation at the 10th annual China International Pharmaceutical Industry Exhibition in Shanghai, Ian Sellick of Pall Corporation, 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.
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 US$300 to US$800 million.
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.
