Freeze drying of biologicals: Process development to ensure biostability lyophilization

摘要

Blologicals, and more particularly biopharmaceuticals, are an important and rapidly growing sector of the pharmaceutical market with estimated market of nearly dollar50bn and over 130 products on the market. Traditionally comprising blood products and vaccines, this group has now been supplemented by a panoply of different molecules expressed as the products of molecular engineering in cell culture; growth factors, recombinant vaccine components and of course a profusion of monoclonal antibodies and antibody fragment fusion proteins. However, these biological molecules are by their nature, as well as a function of their manufacture and extraction, susceptible to degradation and deterioration. For this reason, the