Paradigm shift for vaccine manufacturing facilities: The next generation of flexible, modular facilities

Abstract

Most vaccines today are manufactured using technologies developed 40–50 years ago, often in facilities of similar antiquity, resulting in complex, uncharacterized products with relatively high production costs. As a result, the vaccine industry today is struggling to meet the challenges of improving existing products and developing new vaccines for unmet medical needs 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 antibody manufacturing. While no single facility or process can meet the requirements of all vaccines, we have developed a new paradigm for vaccine manufacturing facilities which exploit the emergence and full acceptance of single use technologies, modern engineering and design concepts, and capabilities of 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 inactivated polio vaccine as a model, we present a new 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.

Cell substrates for the production of viral vaccines

“…Galliher and Pralong present a new paradigm where high modularity of the facility is outlined as the best way to enable both rapid and efficient deployability to new markets and multiproduct manufacturing operations at a lower cost [82]. The solution consists of making spaces more flexible and reducing operating costs through the extensive use of disposable single-use equipment and components in pre-assembled modular suits.…”

“…New concepts allowing faster building and commissioning of vaccine facilities associated with reduced capital and operational expenditures are currently emerging [66,79,[82][83][84]. Galliher and Pralong present a new paradigm where high modularity of the facility is outlined as the best way to enable both rapid and efficient deployability to new markets and multiproduct manufacturing operations at a lower cost [82].…”

A Single-use Strategy to Enable Manufacturing of Affordable Biologics

“…The continuous nature of a perfusion operation also makes it a great candidate for continuous processing of biopharmaceutical proteins. Implementation of perfusion reactors has been successfully commercialized, ranging from large biopharmaceutical companies such as Pfizer, Genentech, Shire, and Genzyme/Sanofi [31] , [32] , [33] to small companies and innovative vaccine manufacturers such as CMC Biologics and Crucell [34] , [35] . Although there are still drawbacks to the technology such as usage of large volumes of medium, and high level of operator training required due to the complexity and intensity of the operation, the economic gain from smaller vessels and facilities has the critical impact on process considerations [18] , [36] .…”

“…2 . The concept is based on standard mAb purification architecture where high throughput of USP and DSP enables production in approximately 20 ft 2 of the GMP suite, which could be itself a modular clean room [35] . One cycle of the DSP, including capture, virus inactivation, polishing, and sterile filtration is designed to be completed in only 24 h.…”

Editorial: Single‐use technology in biopharmaceutical manufacturing

“…In a second Review Pralong et al. prove that single‐use systems are advantageous for the rapid realization of vaccine productions up to biosafety level 3. Two research articles comparing product expressions in stirred and wave‐mixed single‐use bioreactors and three Research Articles describing the scaling‐up of stirred single‐use bioreactors follow.…”