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The Aeras Global TB Vaccine Foundation, a Rockville nonprofit that is developing tuberculosis vaccines, held a grand opening Monday of its new 9,000-square-foot manufacturing facility.

The new plant complements its 6,500-square-foot facility that opened in 2006. Together, they give Aeras the capability to take tuberculosis vaccines under development from cells in the lab to vaccines in vials and capsules, according to spokeswoman Annmarie Leadman.

"The expansion of our facility will enable Aeras to pursue a promising initiative to deliver vaccines directly into the lungs via aerosol formulation," Leadman said in a statement. "Many of our machines are one-of-a-kind having been customized specifically to Aeras' needs and make this a unique BioSafety Level-2 facility."

Whiting-Turner of Baltimore was the general contractor on the project, which provided more than 100 construction jobs. Since 2006, Aeras has invested $23 million in its manufacturing facilities.

A good chunk of that money has come from the Bill & Melinda Gates Foundation, which since 1999 has given Aeras $308.6 million.

Aeras is the Gates foundation's only nonprofit beneficiary with its own manufacturing facility, Leadman said. The idea is to accelerate development and keep costs low, so that vaccines can be affordable in developing nations.

Also, Aeras and its partners have launched a phase 2b proof-of-concept clinical trial of a new TB vaccine developed at the University of Oxford (U.K.). The trial will be conducted in South Africa. The patients: about 2,784 babies under 1 year old who have already received another vaccine. The new candidate is intended to enhance the body's response to the previously administered vaccine.

Aeras' partners are the Oxford-Emergent Tuberculosis Consortium, Isis Innovation, the Wellcome Trust and the University of Cape Town.

Aeras has also begun a phase 1 trial in South Africa of another vaccine candidate that it has developed with Crucell, a Dutch biopharmaceutical company. That trial will be conducted on 54 healthy babies.

The incidence of tuberculosis is on the rise. Globally, there were about 9.27 million cases in 2007, up from 9.24 million in 2006, 8.3 million in 2000 and 6.6 million in 1990, according to the World Health Organization. The vast majority of cases were in Asia, with 55 percent, and Africa, with 31 percent. About 1.8 million people died of TB in 2007.

"The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort," said Jerald C. Sadoff, president and CEO of Aeras, in a statement.

"This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world's deadliest diseases," said Fuad El-Hibri, chairman and CEO of Rockville biotech Emergent BioSolutions, which is teaming with the University of Oxford on the TB project.