Milton B. Dobkin

Antibody levels in reduced/alkylated intravenous immune globulin

Antibody titers, found in representative lots of a reduced and alkylated intravenous immune globulin, against a variety of common microorganisms are presented. With the more frequently occurring pathogens the specific antibody level does not vary significantly between lots. Depending upon the type of assay used, antibody titers per se may or may not reflect the therapeutic activity of the preparation against a specific microorganism.

Varicella zoster antibody titers after the administration of intravenous immune serum globulin or varicella zoster immune globulin

Varicella is a serious infection in the immunocompromised patient. Prophylaxis with varicella zoster immune globulin is known to decrease the incidence of severe varicella infection. The titers of antibody to varicella zoster virus were compared in patients who received either varicella zoster immune globulin or intravenous immune globulin, 4 ml or 6 ml/kg per dose. The titers of antibody to varicella zoster virus were comparable in each group.

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.

Process-scale purification of immunoglobulin M concentrate.

An IgM concentrate was purified from Cohn fraction III. Efficiency of euglobin precipitation was shown to be controlled by pH and ionic strength. Prekallikrein activator activity in the product was insignificant. Overall yield from the octanoic acid supernate and purity of the concentrate were 66 ± 8 (n = 16) and 50 ± 5% (n = 16), respectively. Solvent‐detergent treatment to inactivate lipid‐enveloped viruses was demonstrated and implemented into the process. Process studies to control residual virucidal agents and C4a generating activity are presented.