allus BioPharmaceuticals Presents Real World Data From Its “Factory of the Future”
(St. Louis, Missouri – April 22, 2013) – Gallus BioPharmaceuticals, LLC (Gallus) today announced performance details of its Factory of the Future today. Gallus built an 8,000 sq ft open-ballroom suite using Xcellerex 2,000 L disposable bioreactors and has been operating it for the last year. To date, four mammalian cell lines have been used in multiple bioreactor runs, demonstrating robust scale-up performance, and clinical materials have been manufactured successfully. This facility demonstrates the ability to change over products with improved sustainability with 90% lower water usage and a single operating team with reduced cross-contamination risk. The facility was completed in Q1, 2011, after less than nine months of construction.
Gallus BioPharmaceuticals is a technology pioneering CMO, offering disposable bioreactors and a unique flexible stainless steel bioreactor alternative. The company has partnered with leading upstream and downstream technology providers to establish independent performance data, making these technical solutions available to clients and enabling them to optimize their process and manufacturing methods.
Mark Bamforth, President and CEO of Gallus, said, “Our CMO model is differentiated from traditional approaches through engagement that makes tech transfer and implementation smoother, transparency and partnering that give our clients active influence, and the ability to offer substantial economic benefits through virtual suite ownership – Gallus’ SuiteSPACE™ model. Combined with the flexibility to design the desired technical platform with help from our continual evaluation of the best available technology, our model delivers very tangible benefits in terms of speed, scalability, long-term costs, and performance results.”
In addition to offering the traditional pay-per-run approach, Gallus’ virtual ownership model gives clients control of dedicated capacity without the cost of traditional capital investment. Over capacity and under capacity problems are still prevalent in the industry, and Gallus’ SuiteSPACE™ model offers the flexibility to access capacity as needed. Gallus funds the build-out of a suite that can be custom designed to the client’s needs, and the client can own the process equipment. This innovative approach offers significant economic benefits over traditional pay-per-run models.
Gallus’ world-class facility in St. Louis is distinguished by an unprecedented 27 years of biologics development and over a decade of commercial cGMP manufacturing, providing deep technical expertise and commercial proof of viability for innovative technologies. Options include flexible stainless steel, fully disposable, and hybrid technologies. Gallus has partnerships with leading providers to offer exceptional modular and portable production trains based on flexible architecture, and as a pure-play CMO, continuously evaluates leading technologies and collaborates with clients to select and optimize their technical solution for their needs.
Mark Bamforth added, “Our vision is to be the most trusted provider of world-class manufacturing and development services for the pharmaceutical and biotech industry. To fulfill this, we must be a technology pioneer and ensure that we make a significant difference to both large and small biotechs and pharma, exceeding their strategic objectives. We are also leading the industry into continuous processing based on constant perfusion, which is another area where we know we can deliver even greater results, and why we offer the Factory of the Future today.”
About Gallus BioPharmaceuticals
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, Missouri, was established in 2010 and acquired a world- class commercial biopharmaceutical manufacturing facility from Johnson & Johnson’s Centocor division in 2011 and has grown its workforce by over 40% since then. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally. The St. Louis facility has been inspected and approved by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services: