Viral Vector Manufacturing

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. Designed for early process development, the Ambr 250 is directly scalable to our larger format bioreactors.

Locus also houses robust formulation development capabilities to optimally deliver biopharmaceutical products through multiple routes of administration. To date, we have developed IV, inhaled, oral, and intraurethral formulations of our viral vectors.

Viral vectors require specific characterization to ensure successful clinical development and regulatory approval. Locus has dedicated analytical development laboratory space for method development, validation, and release testing across numerous analytical techniques.

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.

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.