The Learning Curve in Bio/Pharmaceuticals
The technologies of HTST pasteurization and UHT sterilization have been refined for many years in other industries. Details
of validation, maintenance of proper safety assurance, and documentation have also been well defined. The tools to generate
thermal-destruction kinetics, test products, and optimize operating conditions simplify the adoption of these technologies
for bio/pharmaceutical manufacture.
These technologies have been developing for many years, and their adoption involves the use of the existing tools to optimize
them for each application. It also requires specific efforts to implement them properly. As continuous-flow processes that
are new to a manufacturing environment, they require training and a different outlook to support this transition. It is a
cultural change, which extends from manufacturing through maintenance, quality assurance, engineering, and management.
Experience in other industries has shown that thorough initial testing of products is important. Screening to determine the
suitability of materials and selecting processing conditions are significant initial steps. Test-processing products thoroughly
is essential to obtain data supporting optimization of these conditions. It is equally essential that testing demonstrates
the performance of the product with down-line unit operations, especially in continuous manufacturing.
Industry participants are finding that HTST pasteurization and UHT sterilization provide another tool for the manufacture
of bio/pharmaceuticals. They have found products for which theses processes are strikingly successful and those for which
they are not suitable. More importantly, perhaps the most interesting benefit is the ability to facilitate the development
of entirely new products.
John Miles, PhD, is president of MicroThermics Inc., 3216-B Wellington Ct., Raleigh NC 27615, tel. 919.878.3777, email@example.com
1. K. Weintraub, "Biotech Firms Race For Manufacturing Breakthrough," MIT Technology Review Business Report, Jan. 30, 2013,
2. A. Jungbauer, Biotechnol. J. 6 (12), 1431–1434 (2011).