IDRI has the unique mission of applying basic research findings to the prevention and treatment of diseases found principally in developing countries. Research efforts at IDRI combine basic science, process development, and the clinical testing of vaccines, therapeutics and diagnostics.

Process science encompasses two areas: 

1) The development of methods and procedures that allow for small or large production quantities using the same defined procedures;
 
2) The implementation of quality control measures to guarantee that products will meet the same standard from batch to batch. 

To guarantee performance, a vaccine or therapeutic product must be safe for use in humans and not cause any undesirable reaction. The product must be made reproducibly at the level of quality established by industry guidelines and government regulations (as is also true for molecules used in diagnostic kits), and it must be made on a scale sufficient for its intended use, which in IDRI's case, is potential global distribution.

IDRI's Process Science team is building the capacity to do its work under GLP (good laboratory practices). The team can currently take a laboratory organism expressing a foreign gene (termed a recombinant organism), such as one prepared by IDRI's Antigen Discovery team, expand the cell population and stimulate the synthesis of the desired product(s) under controlled conditions in a large biological reaction chamber, and purify the products in a manner that can be transferred to large-scale manufacturing plants. In addition, the team will soon have the capability of stabilizing large quantities of the purified products by freeze-drying (lyophilization). To verify the identities of the purified products, the team routinely employs advanced analytical tools including HPLC, characterization of enzymatic digestion fragments of the protein products, and various types of biophysical analyses. Such tests ensure the purity, quality, safety, and potency of the preparations.

The desired goal behind developing these process steps is the ability to efficiently move from the scale of test product production to the large-scale manufacturing of vaccine or diagnostic material. The careful design and implementation of procedures by the Process Science team at IDRI allow for transfer of processes and procedures directly to an industrial partner who will move to the large-scale production of material for additional clinical tests and eventual global use of the vaccine or therapeutic material. We are currently manufacturing a cGMP (current Good Manufacturing Practices) product in collaboration with the Walter Reed Army Institute of Research with the goal of releasing a new vaccine by the end of this year.