Locus Manufacturing

We built a world-class facility to manufacture our crPhage precision antibacterial products, providing scalability through clinical development into early commercialization for pharmaceutical markets globally.

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Locus Manufacturing

Product Development

Products

We built a world-class biologics manufacturing facility, enabling the manufacture of our precision therapeutics while providing the capability to also manufacture gene therapy vectors and other advanced biologics.

Our facility design allows for parallel production of multiple drug substances simultaneously, in isolated production suites, without risk of cross-contamination. It is optimized for viral vector manufacturing, including bacteriophage, adenovirus, AAV, and other vectors. Taken together, our facility and proprietary production processes allow for all viral products manufactured by Locus to meet or exceed US and international regulatory standards for parenterally administered drug products for clinical and commercial use.

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Development

Our advanced biologics manufacturing facility was designed to provide the company with the ability to optimize viral vector production end-to-end.

The site supports upstream and downstream development focused on amplification titer optimization and removal of impurities through a serious of DOEs studying various excipients and concentrations across surfactants and buffers. In addition to the facility, there are processes in place for phage and bacteria bank production and release, as well as processes to maximize viral titer amplification while removing host cell protein and endotoxin.

GMP Manufacturing

Territories

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.

Control

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.

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