Pall filtration simplifies vaccine production

Conjugate vaccines to protect infants and young children from infectious diseases such as meningitis and invasive pneumonia will become more widely available as their long, complicated and expensive production process can be simplified.

Ultrafiltration technologies, such as those available from Pall Life Sciences, can reduce production time and costs by streamlining many of the 30 or more steps often required to separate and purify conjugate vaccines.

Vaccines to prevent serious infectious diseases such as meningitis, invasive pneumonia and ear and blood infections caused by the pneumococcus bacteria are generally less effective in infants and young children, as their immune systems are not mature enough to produce the required antibodies for protection. The development of conjugate vaccines has enabled protection of children at an earlier age against these types of diseases. They combine foreign protein and polysaccharides (the cell wall of an infectious bacteria) that help the immature immune system recognise and remember the needed immune response.

Despite the benefits of conjugate vaccines, the complex and expensive manufacturing process has presented a barrier to wider-scale use.

'Pall's innovative purification technologies are used in critical processing steps to manufacture these life-saving vaccines more efficiently and economically,' says Ian Sellick, director of marketing, Pall Life Sciences. 'With the emergence of drug-resistant bacteria the need for conjugate vaccines is even more critical.'

Purification methods account for as many as half of the production steps to manufacture conjugate vaccines, and ultrafiltration technology can reduce production time and cost in many of these.

Pall's Centrasette ultrafiltration technology provides a more efficient alternative than existing separation methods. A core step during conjugate vaccine production is fractionation, which is used to separate polysaccharides into specific size classes for attachment to proteins. While fractionation is traditionally performed using size exclusion chromato-graphy, ultrafiltration provides a faster, simpler method of capturing specific size polysaccharides. Ultrafiltration also eliminates the need for costly chromatography resins.

The pneumococcus bacterium is the leading cause of invasive and noninvasive bacterial infections in the US. Although pneumococcal disease affects persons of all ages, infants and children age five and younger are especially prone to infection. Each year, about 17,000 cases of invasive pneumococcal disease (e.g. bacteremia, meningitis) occur in children younger than five years, and an estimated 200 children die of the disease. In addition, pneumococcus is a common cause of community-acquired pneumonia, and acute otitis media in children.¹