Regulatory / Quality Assurance

Under the guidance of the Aeras Regulatory QA Group, the Aeras Vaccine Development Laboratories and the Process Development and Manufacturing groups have developed and continue to develop numerous SOPs to meet compliance with safety regulations and guidelines, Recombinant Organism (GMO) guidelines, current Good Manufacturing Practices (cGMP) regulations including Installation Qualification (IQ) and Operational Qualification (OQ) validation of facilities and equipment. Aeras welcomes enquiries about SOPs from other laboratories and manufacturing facilities.