Gallus’ state-of-the-art cGMP facilities in St. Louis and Princeton, have been producing biologics for nearly three decades and manufacturing commercial products for over 10 years. We continually invest in expanding and upgrading our facilities to provide the flexibility that differentiates Gallus from other CMOs.
Our commercial facility in St. Louis currently has five ISO 8-classified suites ranging from 500 L – 2,000 L multiple bioreactor scale, and an ISO 5-classified multipurpose suite.
Suites 1 to 4 are approved for commercial manufacturing and Suites 1 and 2 are dedicated to an existing client for commercial manufacturing.
Suites 3 and 4 are multi-client suites for clinical and commercial manufacturing using multiple 500L stainless steel bioreactors or up to 2 x 2000 L single use bioreactors.
Suite 5 is an open ballroom cGMP production suite designed with a high degree of flexibility. It is comprised of Xcellerex® disposable 50 L – 2000 L scale bioreactors and downstream Controlled Environmental Modules (CEMS) for production of Phase I-III clinical or commercial products.
Our Princeton facility includes a pilot plant with 50 L and 200 L scale Stainless Steel and single-use bioreactors and Stainless Steel bioreactors up to 2000 L scale and single use bioreactors up to 1000 L scale in multiple rooms, for clinical supply, in addition to liquid-vial aseptic fill-finish.
Gallus is a pioneer in deploying advanced technologies and continuously evaluates equipment to provide the best possible solutions for our clients. We partner with leading technology providers to offer exceptional modular equipment trains based on disposable and flexible stainless steel architecture. We always collaborate with our clients to ensure that the technical solution aligns with our client’s needs and preferences to ensure the achievement of desired outcomes.
Services
- cGMP clinical supply (Phase I/II/III) Drug Substance manufacturing
- cGMP launch and commercial supply Drug Substance manufacturing
- Master Cell Bank and Working Cell Bank cGMP manufacture
- cGMP Cell Bank Storage
Facilities
- Pilot Facility
- Multiple Clinical and Commercial Suites
- Dedicated SuiteSPACE® Model Capacity
- Clinical Fill-finish Suite