The Vaccine Scene - A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma. This article is part of a special section on vaccines. - BioPharm International

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The Vaccine Scene
A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma. This article is part of a special section on vaccines.


BioPharm International
Volume 26, Issue 2, pp. 18-20, 57

CHANGING THE FACE OF PRODUCTION

To increase capacity, companies using today's roller bottles have two options: increase the number of roller bottles or cell stacks, or implement stirred-bioreactors at large volume with microcarriers. Each has its drawbacks. Increasing the number of bottles or stacks means that additional cleanroom space and experienced labor (more capital) are required, which also brings an increase in contamination risks, as well as compromised consistency. Implementing stirred reactors at a large volume with microcarriers presents process development challenges, requires additional intermediate bioreactors, increases operating and manufacturing costs, and extends time horizons for results.


Figure 1: Scale-up comparison of Integrity iCELLis bioreactor with roller bottles.
In the face of the cost and risk deterrents, it became clear that there were new opportunities to bring efficiencies and increase return on investments by taking a different approach to the challenge.An alternative approach is presented below, which bypasses some of the historical difficulties of scale-up. This approach uses three criteria for cell growth/viral production technology:
  • Intensification: Instead of worrying about chained scale-up issues through multiple processes, ATMI designed an approach that delivered a scale-up in a single process. In doing so, it found it could achieve an intensified process result with less required volume inside a smaller footprint. This meant no additional buildings, space, or utilities required to achieve an increase in production.
  • Simplification: The scale-up process is simplified, which diminishes key factors such as cost, GMP/compliance requirements, and potential risk of errors.
  • Single-use solution: The process uses the Integrity iCELLis bioreactor, a single-use, packed-bed bioreactor that can accommodate up to 500 m2 of surface area in a 25-L volume by using medical-grade microfibers in a compact fixed-bed. This volume is equivalent to around 3000 roller bottles of 1700 cm2 (see Figure 1).

This approach offers a bioreactor system with a simplified, minimal seed train requirement in which biomass would be multiplied by up to 500 times. Consequently, the Integrity iCELLis bioreactor can be inoculated at a very low cell density, and no preceding bioreactor is needed for seeding. In addition, the biomass is immobilized to avoid mechanical constrains at very high cell density and avoid additional perfusion tools. Because the system is compact, there is no need to increase the size of infrastructure to implement the capacity increase, enabling commercial-scale manufacturing in a typical laboratory environment

CONCLUSION

Innovation in process design is vital in meeting the world's growing vaccine demand. A technology such as the iCELLis bioreactor provides mass scale-up for vaccine production and enables commercial-scale manufacturing results. In the present day, speed to market and streamlined development are more crucial than ever before. As long as markets remain unsatisfied with the traditional pace of progress, innovation will continue to open the doors to the next levels of bioprocess advancements and breakthroughs.

Jose Castillo, PhD, is director of cell-culture technologies at ATMI LifeSciences,
.

REFERENCES

1. Research and Markets, Human Vaccines: A Global Strategic Business Report (San Jose, CA, January 2011).

2. A. Hiller, "Vaccines Continue to Bolster Pharma Market," Dec. 2, 2010, http://www.pharmpro.com/articles/2010/12/busines-Vaccines-Continue-to-Bolster-Pharma-Market/, accessed Jan. 7, 2013.

3. ATMI, In-house market research: desk searches (companies and Institutions websites) and meetings with NOAH and ANSES (2012).


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