ABSTRACT
Over the two has from a lat)orat()ry science to a viable industrial with advances that have led to the development and commercialization of new medications for a of diseases. The U.S. Food and Administration has at least two dozen or antibodies for cancers, immunological and and other diseases. In the years of biotechnology, manufacturers realized that protein products would require special care in the final formulation because of two Proteins are with small amounts per dose necessary for . This would indicate formulation in a dilute solution. On the other proteins are generally unstable in solution. The dilemma was resolved lyophilizing dilute solutions of and this became the in the 1980s. Althclug:h the number of solution forms for has increased considerably in the present is still the only pnlctJicable stabilizing method for some
Lyophilization technology, adapted from eXlstlmg rw'o"tiN'" in fom1Uwas at first to nrc)teins.
However, research into refining the process for proteins was undertaken, and problems associated with protein stabilization and dosage form lyophilization cycle development received a great deal of attention. In contrast, issues relating to the container closure system were largely neglected. Yet without an adequate and compatible closure, the advantages of lyophilizing a biopharmaceutical product cannot be fully realized. In this chapter, we discuss the use of elastomeric closures for biopharmaceutical freeze-dried products and offer some explanations and solutions based on our own experience in this field.
