Locus -GMP Manufacturing Services
With an eye on servicing healthcare markets globally, we built a 10,000 sq ft modular facility that can meet the standards of the US (FDA), Europe (EMA), Japan (PMDA), and several other countries and regions. The architectural layout and HVAC design ensure the robust biocontainment of organisms within the BSL-2 facility that meet all CDC, NIH, WHO, and ECDC requirements. At the heart of the facility are the three self-contained manufacturing suites: upstream, for bioreactor culture and harvest; downstream, for purification and formulation; and aseptic, for filling and finishing.
Our award-winning, 100% single use manufacturing facility was designed to control contamination risk through each step of the manufacturing process.
Viral vector manufacturing facilities are subject to contamination risks, particularly with a ubiquitous organism like bacteriophage. By employing single use systems with no traditional utilities (e.g., no water for injection, clean steam, or drainage systems), we can limit the risk of contamination through the amplification, purification, and polishing steps. Furthermore, our self-contained, aseptic fill and finish system, the Vanrx Microcell, ensures efficient filling and high product quality standards.