A shot in the arm for vaccine manufacture
Using innovative nanotechnologies, an EU-funded project is developing more efficient and sustainable vaccine manufacturing processes. The cost of vaccines puts a brake on wider immunisation, so these new processes will find broad application - especially in developing economies.
© Mike Fouque - fotolia.com
Great advances have been made in developing and introducing new vaccines for a wide variety of diseases and infectious agents. More people than ever, and more children than ever, are vaccinated against diseases such as hepatitis, measles and meningitis, among many others.
Nevertheless, despite this progress, vaccine-preventable diseases remain a major cause of illness and death, especially in developing countries. There are a variety of reasons for this, and cost is one of them vaccines can be expensive.
The EU-funded DIVINE project is developing an innovative approach to vaccine manufacture to reduce these expenses. Its partners are implementing two major nanotechnology innovations to produce an integrated vaccine purification platform offering a drastic reduction in processing costs.
This platform will be of major significance for developing countries, which manufacture about half of UN-funded vaccines and for whom processing costs are a major obstacle to wider immunisation programmes.
And DIVINEs partners wont stop there after the project ends in February 2020, says project coordinator Manuel Carrondo of Portugals Instituto de Biologia Experimental e Tecnológica.
Our interest goes further, Carrondo says. Vaccines are a complex case in the processing of biological materials. If we can prove the DIVINE technology on vaccines then we believe it is transferable to other biologicals, such as blood products that could be used to treat haemophilia and gene therapy vectors developed to combat genetic diseases.
A novel approach
The first steps of traditional vaccine production result in a mixture of the vaccine itself and a soup of impurities. Each of these impurities is then stripped out in several purification steps, leaving the pure vaccine behind. These steps account for up to 80 % of manufacturing costs.
DIVINE takes a novel approach. Rather than gradually stripping out impurities, the project developed a special process, called affinity-capture, which extracts the pure vaccine directly from the impurities.
By using affinity-capture we may reduce the number of process steps to two or three and improve yields significantly, says Mikkel Nissum, technical development leader for vaccines at pharmaceutical company GSK, a project partner.
The process uses a special class of proteins that bind to specific vaccine molecules, developed by project partner Affilogic, a project partner.
Our research so far has been on identifying suitable proteins, explains Olivier Kitten, Affilogics CEO. Already we have a candidate that could be used to make, for example, vaccines against major bacterial diseases such as pneumococcal infection. This candidate is moving into pilot testing and others are following quickly our second candidate is currently being evaluated.
Suitable proteins will then be immobilised on a solid support to create a chromatography resin designed for the affinity capture of a specific vaccine.
The combination of Affilogics specific proteins with Merck´s innovative chromatography resin platform will establish a broadly applicable technology platform to facilitate the purification of vaccines, says Jonas Anders of Mercks Life Science Division, a project partner.
A further DIVINE innovation is to purify and reuse the large volumes of water employed in vaccine production. This uses a new biomimetic membrane technology developed by water technology company Aquaporin, a project partner. The technology allows pure water to pass through while blocking impurities, explains Claus Hélix Nielsen, Aquaporins chief technology officer.
The ultra-clean water needed for vaccine production is a valuable resource, especially in emerging country manufacturing plants, he says. By implementing Aquaporin Inside technology as part of the affinity-capture process we can reduce costs, waste and environmental burdens, and develop less aggressive manufacturing processes, which will improve vaccine yields.
At present, different Aquaporins membranes are undergoing laboratory tests while appropriate quality control benchmarks are developed for this novel technology.
DIVINEs next step will be to move the technologies into the pilot manufacturing stage.