Gallus Biopharmaceuticals, LLC

4766 LaGuardia Drive
St. Louis
Missouri
63134
United States

Tel: 314-426-5000
Fax: 314-426-1792

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About Gallus Biopharmaceuticals, LLC

Gallus BioPharmaceuticals has recently emerged on the market as a premier cGMP biologics contract manufacturing organization based in St. Louis, MO USA. Gallus operates an FDA-approved, commercial facility formerly owned by Centocor Biologics. The plant has been approved by every major regulatory agency and currently manufactures two of Centocor Biologics’ leading products, Remicade® and Stelara™, which are distributed globally. The Gallus facility has capabilities for clinical and commercial mammalian cell culture in batch, fed-batch and perfusion as well as process development and analytical services. Gallus’ business model incorporates the idea of virtual ownership of a dedicated suite, or “condominium” approach to biomanufacturing, along with the traditional pay-per-run or “timeshare” contract manufacturing. This novel approach provides clients with complete flexibility in accessing capacity as needed. This flexibility has been further enhanced under the partnership with Xcellerex and the turnkey XcellerexFlexFactory® cGMP manufacturing platform.
Facility and cGMP Manufacture The Gallus facility has over 30,000 square feet of laboratory space for process development and clinical and commercial cGMP manufacture of mammalian cell culture-based biotherapeutics. The Clinical Services Suite (CSS) is a full-service cGMP production suite designed with a high degree of flexibility utilizing state-of-the-art disposable and scalable equipment for the production of Phase I / II and III(pre-process validation) clinical material. The Gallus commercial facility has four suites, from 500L to 2000L bioreactor scale. The facility can accommodate up to 4 future "condo" suites which will have cell culture fermentation at 2000L with room for up to 4 bioreactors per suite for a total of 8000L, along with appropriate scale downstream operations. All suites are designed for flexibility to utilize portable equipment, and can be easily reconfigured to meet a customer’s specific needs. There is also an ISO 7 classified suite for cGMP Cell Bank manufacture and for small cGMP fill finish activities.
Process and Analytical Development The Gallus process development laboratories are designed to support development, technical transfer, and optimization of processes and analytical methods for clinical and commercial production. The group has considerable capabilities with a variety of host cell types and manufacturing processes and experience with multiple tech transfers, process optimization and development for many projects.
Gallus Culture Gallus was created with the goal of taking a high quality, high performing team with a storied history of developing and producing biopharmaceuticals, and infusing this team with an entrepreneurial vision to build a world-class Contract Manufacturing Organization. To learn more about Gallus, please visit our website at www.gallusbiopharma.com.

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