AERAS

Aeras' manufacturing facilities are located at Aeras' headquarters in Rockville, Maryland, USA. The state-of-the-art current Good Manufacturing Practices (cGMP) facilities are designed to produce 200 million bulk doses of a live recombinant BCG vaccine per year — enough to meet the estimated need worldwide. The new facility will allow Aeras to manufacture rBCG as well as viral, protein and capsid vaccines and will contain new state-of-the art equipment for lyophilization ("freeze drying") and spray drying. New vaccines will be manufactured in bulk at Aeras or at partner facilities, then filled and finished by partners operating in China, India, Korea and possibly elsewhere and distributed where needed at the lowest possible price.

Completed in 2006, the original "upstream" manufacturing facility uses the most advanced technology, some of which Aeras pioneered. In addition to producing new TB vaccines, the facility also has the capacity to support the vaccine manufacturing needs of product development partnerships pursuing the development of vaccines for HIV, malaria and respiratory infections.

In 2009, Aeras added a new "downstream" TB vaccine manufacturing facility — a Biosafety Level-2 cGMP facility. It brings Aeras the in-house capacity to support all the steps necessary to create powder, liquid and lyophilized formulations of vaccines. The facility fully complements the capacity Aeras already possesses in its "upstream" facility. TB vaccines under development will move from the cell bank to process development and fermentation in the existing "upstream" facility and then to the "downstream" facility for purification and filling into vials or capsules.

Spray drying to create powder formulations for aerosol delivery is one of the leading scientific advancements Aeras has pursued. Pre-clinical studies of aerosolized TB vaccines show better immune response in the lung. They also promise to be more affordable.

The manufacturing facilities are adjacent to the Aeras development and research laboratory, offering the advantage of easy transfer of technology and knowledge from the laboratory to manufacturing. Aeras took the novel step of building its own facilities to ensure uniformity of quality, adequate supply, the lowest possible cost and the elimination of lag time between licensure and distribution. Affordability and availability at the soonest possible date are key components of the Aeras approach to future access to new TB vaccines.