Application of a caprylate/chromatography purification process for production of a high potency rabies immune globulin from pooled human plasma.

BACKGROUND: Human rabies immunoglobulin (RIG) is an integral part of post-exposure prophylactic treatment of rabies (along with rabies vaccination). Infiltration of most, if not all, of the RIG dose at the wound site is recommended. RIG produced by a caprylate/chromatography manufacturing process (RIG-C; HyperRAB) increased the potency and purity of this product over the existing licensed RIG from a solvent/detergent process (RIG-S/D; HyperRAB-S/D). METHODS: A series of studies were conducted to characterize the content and purity of RIG-C. A single-dose pharmacokinetic study in rabbits was performed to compare intramuscular (IM) immunoglobulin products manufactured by two different purification processes, solvent/detergent (IGIM-S/D) and caprylate/chromatography (IGIM-C). RESULTS: RIG-C was found to be a highly purified IgG formulation with high monomer content and formulated with twice the anti-rabies potency of RIG-S/D while maintaining the same overall protein concentration. RIG-C facilitates IM administration at the wound site by halving the injection volume. The new caprylate/chromatography process eliminated detectible levels of pro-coagulant impurities and IgA that were carried through in the prior S/D process. These impurities have been associated with thrombotic complications and allergic reactions in susceptible patients. After single dose administration, IGIM-C was pharmacokinetically equivalent to IGIM-S/D in rabbits. CONCLUSION: RIG-C is a more potent RIG formulation with less impurities yielding a safer and more convenient product with similar pharmacokinetic profile.

A blueprint for professionalizing humanitarian assistance.

International humanitarian response to crises employs 210,000 people and accounts for nearly $15 billion in spending globally each year. Most action is carried out by not-for-profit organizations working with United Nations (UN) agencies, military organizations, and commercial entities. UN agencies employ many technical experts, often retaining them for five or more years. As yet there is no international professional apparatus to promote the quality and integrity of this workforce. This paper reports on research exploring the case for professionalizing humanitarian action through an international professional association, the development of core competencies, and the creation of a universal certification system for aid workers.