Process Development and Manufacturing
The Aeras Process Development and Manufacturing Group develops cGMP manufacturing processes for fermentation, cell harvest and preservation of Aeras rBCG and capsid vaccines. The Process Development laboratories consist of areas for fermentation at 10 L scale, cell harvest, purification, formulation, lyophilization, and spray drying. Aeras' cGMP vaccine manufacturing facility has the capabilities of producing Master Cell Bank, Working Cell Bank, and vaccine bulk at 20L-200L scale. The facility was designed to meet the regulatory guidelines established by the WHO, the US Food and Drug Administration and the European Medicines Agency. It also was designed to accommodate Biosafety Level 2 microorganisms. The facility is equipped with a heating, air conditioning and ventilation (HVAC) system engineered to protect both the products and the personnel by using separate air handling units and appropriate pressure differentials for the production rooms. The air classifications for the controlled environments are determined by the operations in the specific areas.
This facility also has advanced fermentation and recovery equipment, a reverse osmosis and deionized water system (RO/DI), a Water-for-Injection (WFI) system, a clean steam system, and a pharmaceutical-grade compressed air system. The major process equipment is sterilized in place (SIP) and cleaned in place (CIP) to ensure both containment and cleanliness. The flow of the materials and personnel through the facility is unidirectional and conforms to cGMP requirements for bacterial vaccine production. For fill/finish, we have set up a system to perform semi-automatic liquid filling up to 2,000 vials per lot. This facility is capable of producing rBCG and other live bacterial vaccine bulks for Phase I-III clinical trials, as well as licensed products for distribution.
The Aeras Process Development and Manufacturing Group welcomes enquires on process development and production of vaccines, as availability of the facility allows. We are not permitted to produce live M.tb vaccine candidates even though they are attenuated, but are willing to produce any rBCG vaccine or other live bacterial vaccines, bulks or supernatants for experimental use as well as for animal and human use.