Locus built an ISPE 2021 Facility of the Year award-winning, world-class biologics manufacturing facility, enabling the manufacture of precision therapeutics while providing the capability to also manufacture gene therapy vectors and other advanced biologics.
The design, a 10,000 sq ft cGMP facility with three modular suites, allows for parallel production of multiple drug substances simultaneously, in isolated production suites, without risk of cross-contamination. Alternatively, Locus could use the production suites for serial processes:
- Upstream processing of high concentrations of potentially virulent and non-virulent bacteria, including the introduction of bacteriophage into bioreactors for amplification of phage
- Downstream processing including clarification filtration, tangential flow filtration (TFF), chromatography, and bioburden reduction filtration
- Sterile filtration and vial/syringe filling
It is optimized for viral vector manufacturing, including bacteriophage, adenovirus, AAV, and other vectors. Taken together, the facility and proprietary production processes allow for all viral products manufactured by Locus to meet or exceed US (FDA) and international regulatory standards (i.e., Europe [EMA], Japan [PMDA], and several other countries) for parenterally administered drug products for clinical and commercial use.
The 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 organisms 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.