Final Word: The Case for Flexible Manufacturing Capacity

The mounting threats of pandemic influenza, bioterrorism, and emerging infectious diseases continue to be the focus of research programs and funding initiatives, not only within governmental agencies, but also universities, private research firms, and commercial manufacturing entities. With all of these efforts, however, the question of manufacturing capacity and the ability to respond to pandemic and emerging threats continues to be a major concern.

Jeff Odum

The development of capital resources that bridge the gap between vaccine R&Dand commercial-scale manufacturing of vaccines is a critical component of the overall strategy of preparedness that the industry must resolve. Several companies receiving US government funding under initiatives such as BioShield do not have internal capacity to push new products down the development pipeline. Such capacity is essential if products are to be licensed, produced at commercial scale, and distributed to the general population.

The expansion of research capacity for emerging infectious diseases sheds more light on capacity concerns. There are currently two national biocontainment BSL-4 laboratories, 13 regional biocontainment laboratories existing or in development, 10 regional centers of excellence for biodefense and emerging infectious disease research, and four new National Institutes of Health (NIH) facilities. However, a similar focus on expanding manufacturing capacity at clinical scale is missing. The pilot plant of the National Institute of Allergy and Infectious Diseases (NIAID) at the Bumpers Vaccine Research Center in Maryland is the only true commercial manufacturing development resource created to support this research.

Vaccine manufacturing is in the midst of a dramatic transformation. Moving away from the traditional model of dedicated production facilities, new capacity will need to be flexible and much more efficiency-focused. To speed the availability of products to the marketplace, development and manufacturing resources must be available.

This effort will need to focus on some key success factors:

• Supporting development of products without the pressure of revenue constraints

• Providing support for "unknown process definition" based on flexibility and new technology

• Industry and government support beyond simply "throwing money" at the problem

• Looking beyond our geographic borders.

With so many products in development, providing flexibility in the operations platform design is critical. A manufacturing resource designed to operate across many different platforms would not be cost effective in the true commercial sense. Meeting regulatory requirements across the international regulatory spectrum would be a must. Additionally, developing a design that can become cost effective by being standardized would allow for multiple sites, dictated by need and funding.

If the R&D efforts currently under way are even remotely successful in the future, will we be able to take advantage of these new products without increasing our manufacturing capacity? Can existing commercial resources be brought to bear in times of crisis? These questions cannot be answered today, but are essential to fill gaps in the critical path of the product lifecycle.

Development of capacity is a strategic necessity to meet the potential needs of the emerging vaccine product pipeline. Additional resources for process and manufacturing operations will ensure that research efforts will move forward into critical Phase 3 trials and will not be delayed due to lack of available manufacturing space.

Jeff Odum is the Principal of NCBioSource, Raleigh, NC, 919.341.3565, jodum@ncbiosource.com.