Virucidal efficacy of saturated intermediate length straight-chain alcohols in biologically active protein solutions

Manufacturing processes for therapeutic products derived from recombinant DNA and hybridoma technology have required a re-assessment of the parameters traditionally applied for inactivation of endogenous viruses. Historically, time, temperature and concentration of the virucidal agent were the variables considered, whereas pH and ionic environment were restricted by physiological concerns to neutral pH and isotonic buffered solutions. Newer processes are less restrictive of pH and ionic environment, and this has permitted exploration of a wider range of virucidal agents and conditions. Intermediate length straight-chain alcohols are highly virucidal at low pH, with diminished activity at higher pH. Decreased activity was demonstrated by derivatives of the alcohols depending on the position of the hydroxyl group. Applications to proteins include monoclonal antibodies.