Conjugate vaccines to protect infants and young children from infectious diseases such as meningitis and invasive pneumonia will become more widely available if their long, complicated and expensive production process can be simplified. One way to reduce production time - and costs - is by the use of ultrafiltration, according to Pall Corp.
Ultrafiltration technologies can streamline many of the 30 or more steps often required to separate and purify conjugate vaccines, said the company in a presentation made at the BIOPHEX/INTERPHEX conference, which started in San Jose, California, yesterday.
Vaccines to prevent serious infectious diseases such as meningitis, invasive pneumonia and ear and blood infections caused by pneumococci tend to be 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, as they combine foreign protein and polysaccharides from the cell wall of bacteria that enhance the immunogenicity of the vaccine antigens.
However, 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," said Ian Sellick, director of marketing at Pall Life Sciences.
Purification methods account for as many as half of the production steps to manufacture conjugate vaccines; ranging from the production and purification of polysaccharides, proteins and conjugates, to sterile filtration of the bulk product. Ultrafiltration technology can reduce production time and cost in many of these steps.
Pall's presentation at BIOPHEX/INTERPHEX describes how its 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 chromatography, ultrafiltration provides a faster, simpler method of capturing specific size polysaccharides," claimed the company. Ultrafiltration also eliminates the need for costly chromatography resins, it said.
Purification of the final conjugate vaccine is another step in the production process. Pall presented evidence that its Mustang technology, an ion exchange membrane chromatography system, provides a polishing step with speed and cost benefits over conventional beaded resin column chromatography.
In addition to the presentation on purification technology for conjugate vaccine production, Pall will be making other presentations at BIOPHEX/INTERPHEX. These presentations cover new technology to streamline transgenic processing, membrane technology as a platform for protein microarrays, the use of membrane chromatography and tangential flow filtration in gene therapy for purification of antisense oligonucleotides, a new technology for aseptic connections and a method of validating pre-sterilised single-use filter capsules.