The use of disposable and scalable technologies to purify large molecule vectors can help manufacturers streamline processes and overcome many of the unique challenges associated with vaccine development, according to separations specialist Pall.
In a presentation at the World Vaccine Congress this week, Pall scientist Dr Helene Pora described how advanced approaches to purification as part of a total process management scheme could help vaccine manufacturers address issues of scalability, validation and process development.
Viral vaccine development is a notoriously long and costly process governed by stringent regulatory controls. As the demand for vaccines increases globally, biopharmaceutical companies need to safely and reliably speed up development and production cycles that typically last 8 to 12 years and cost between $300 and $800 million, she told the meeting.
Disposables offer lower installation costs compared to stainless steel systems and eliminate cleaning and cleaning validation. These factors can lower labour 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 Dr Pora.
"With the cancer vaccine market predicted to reach $6 billion by 2010, efficient production will require flexibility and scalability. Disposable technologies capable of efficiently processing larger volumes will play a pivotal role in moving the majority of vaccines from clinical trial to full-scale manufacturing," she added.
In her presentation, Dr Pora demonstrated the higher binding capacity of single-use Mustang membrane capsules for large molecule applications compared to conventional resin- or gel-based column chromatography.
She described a process that also incorporated the use of disposable prefilters, sterilising grade capsules and final filters to provide time, cost and labour savings.
This process management approach can also help companies comply with the new Good Manufacturing Practice (GMP) regulations that came into force last May, and particularly Annex 13 which set out new specifications for the manufacture of clinical grade products.