Scale-up Development

There are three major stages in the development of a vaccine: research leading to antigen discovery, development leading to a small-scale manufacturing process for clinical materials, and manufacturing leading to large-scale mass production of the vaccine for worldwide use. Creating a robust, reproducible manufacturing process is key to ensuring a long-term supply of high-quality vaccines. For vaccine development, the laboratory process produced during the discovery phase cannot be directly used for vaccine production at large manufacturing scale. Detailed experiments are needed to ensure that products can be made reproducibly over a span of many years. For years, Creative Biolabs has consistently and effectively supported the vaccine industry with a unique range of products and related services. We provide scale-up development to ensure a long-term supply of high-quality vaccines and mass production of the vaccine for worldwide use.

Vaccine manufacture and licensure are facility, equipment and process-dependent, which means that the process defines the product. Vaccines are often complex mixtures of antigens and impurities, making the reproducibility of the vaccine substance dependent on the manufacturing process. Creating a robust, reproducible manufacturing process is key to ensuring a long-term supply of high-quality vaccines. Regulators around the world are aware of these issues and operate on the principles that the process defines the vaccine. Process development, equipment selection and facility design define the final vaccine production process and must reflect the science behind the vaccine.

Scale-up Development

Fig.1 The progression of product and process development from laboratory method and phase I trials, to large-scale manufacturing process and phase III trials, leading to licensed product launch. [1]

Case Study: Large-scale Manufacture of HIV Vaccines

The generalized processing steps involved in the manufacture of an AIDS vaccine are as follows:

  • Master and working seed banks: To ensure that the starting materials are identical for each batch, all biological processes begin with a vial from a certified seed bank system for microbial or animal cells, or virus.
  • Growth: Fermentation in a series of increasingly large bioreactors develops the desired quantities of cells to produce the product. In viral processes, the cells are usually grown to maximum density, then infected with the virus and maintained to maximize virus production.
  • Harvest: The active vaccine intermediate is separated from the growth media using cross-flow or dead-end filtration, or centrifugation.
  • Purification: The active vaccine intermediate is purified by filtration and chromatography.
  • Bulk filling: Purified vaccine intermediate is formulated to final bulk, or API, specifications and filled into appropriate sterile bulk containers.
  • Final product filling and packaging: Final formulated vaccine is filled into syringes, vials or other final delivery containers, lyophilized if necessary, labeled, packaged and prepared for shipment to the final destination.

Once the candidate vaccine is selected through pre-clinical trials and phase I/II clinical trials, process development should be initiated. The current regulation is that clinical materials must be closely representative of the final product and must be made in cGMP compliance. The transformation from laboratory methods to industrial processes adds many layers of scientific, technical, regulatory and organizational knowledge to vaccine production. The application of knowledge and wisdom in the various fields involved in vaccine industrialization usually produces a successful product.

As vaccine manufacturing specialists, Creative Biolabs has a wealth of expertise and access to the world's most advanced manufacturing equipment. We fundamentally understand the processes involved in scale-up vaccine manufacturing, the capabilities of the technologies used, and the engineering designs required to ensure that you operate optimally with the lowest possible maintenance costs.

Reference

1. Donald, F. (2007). “Vaccine Scale-up and Manufacturing.” Vaccine Industrialization Chapter, 17.


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