We have built two broad and agile platforms that allow us to rapidly respond to areas of medical unmet need. Our bacteriophage therapeutics are designed to precisely remove pathogenic bacteria from the human body or leverage the microbiome to deliver precision medicines. Our award-winning manufacturing facility allows us and our partners to rapidly produce drug products for clinical development and early commercial launch.
Locus Biosciences has built a powerful biopharmaceutical development platform that enables us to develop products that selectively remove bacterial species or exploit bacteria to produce payloads that may be beneficial in treating diseases in multiple therapeutic areas.
Utilizing high-throughput robotics, Locus rapidly identifies and characterizes bacteriophage libraries for any bacterial target. We collect natural bacteriophages from the environment, then isolate and characterize phages with the desired properties. These selected phages are subject to next-generation DNA sequencing, which enables Locus to rapidly capture the genomic sequence of each phage. This data is integrated to rapidly select bacteriophages for engineering and to combine promising phages into cocktails that can kill the vast majority of the clinically-relevant strains of the target bacterial species.
Locus is the world’s leading developer of engineered bacteriophage products. This enables us to combine or manipulate traits that natural bacteriophage may not have, enhancing desirable phage attributes or diminishing unfavorable characteristics. With each phage characterized and subsequently engineered, Locus captures data so that proprietary informatics and machine learning algorithms can further automate future engineering processes and support data-informed decision-making.
Leveraging machine learning and data-informed predictions, Locus builds cocktails of the best nominated phages. These cocktails are subjected to a battery of in vitro and in vivo tests, creating millions of data points that further inform which cocktail to select for clinical development.
Locus Biosciences has built an ISPE 2021 Facility of the Year award-winning, world-class biologics manufacturing facility, enabling the manufacture of precision therapeutics.
Employing high-throughput, multi-parallel prototyping bioreactors like the Sartorius Ambr 250, Locus tests multiple process parameters to establish upstream and downstream manufacturing processes that are reliable and cost-effective in meeting all critical quality attributes. Locus also houses robust formulation development capabilities to optimally deliver biopharmaceutical products through multiple routes of administration.
Locus operates an award-winning 10,000 sq ft modular cGMP manufacturing facility, capable of serving early development through early commercial launch and which conforms to the biopharmaceutical manufacturing standards of regulatory authorities in the US (FDA), Europe (EMA), and Japan (PMDA). The architectural layout and HVAC design, which includes appropriate pressure drops and separate air handling units for each manufacturing suite, ensure the robust containment of chemical and biological raw materials within the biosafety level 2 (BSL-2) facility. At the heart of the facility are the three self-contained manufacturing suites that enable simultaneous production of up to three different assets in the facility.
Viral vector manufacturing facilities require a higher level of containment and facility controls relative to other biologics modalities to prevent contamination. Our manufacturing facility was designed to utilize all single-use materials to minimize contamination risk through each step of the manufacturing process.
Locus uses a self-contained sterile fill and finish system, the Vanrx Microcell, to ensure efficient filling and high product quality standards.
Viral vectors require specific characterization to ensure successful clinical development and regulatory approval. Locus has dedicated analytical development laboratory space for release testing, method development, and validation across several analytical techniques.
Locus maintains a robust quality control system to ensure that compliance standards are met across all major regulatory bodies. In addition to in-process and release testing of cGMP drug substances and drug products, Locus employs industry-standard quality management systems.
If you are interested in working with us on developing precision medicines, please reach out below.