Paradigm shift for vaccine manufacturing facilities: The next generation of flexible, modular facilities
By: Alain Pralong, Howard Levine, Jan Lilja, Asa Gaasvik, Hans Hummel
Please note that the publishers of Engineering Life Sciences do not allow the posting of reprints from their journal. Therefore, we are providing, free of charge, a copy of the accepted version of the article which has been published on the publisher’s website Engineering Life Sciences, May 22, 2014
Most human vaccines today are manufactured using technologies developed 40-50 years ago, often in facilities of similar antiquity, resulting in relatively complex, uncharacterized products with relatively high cost. As a result, the vaccine industry today is struggling to meet the challenges of improving existing products and processes and developing new vaccines for unmet medical needs, all at an economical cost.
The unique nature of each vaccine manufacturing process makes it difficult to develop standard platform processes and facility designs similar to those used in monoclonal antibody manufacturing. However, while no single facility or process can meet the requirements of all vaccine products, we have developed a new paradigm for vaccine manufacturing facilities which exploits the emergence and full acceptance of single use technologies and today’s modern engineering and design concepts and capabilities for modular construction.
Modularization of facility design and construction and the application of single use technologies permit rapid construction and commissioning of vaccine facilities while significantly reducing the capital and operational expenditures required for such facilities. Using inactivate polio vaccine as a model, we present our new facility design concept which can be rapidly deployed in different locations adapted to market and/or tender strategies without incurring the risk or cost of excess process architecture and drug product changes.