Advanced single-use biomanufacturing facility designed and built in just nine months
St. Louis, Missouri, USA and Chalfont St Giles, UK – 27 October 2014 – Gallus BioPharmaceuticals, LLC, (Gallus), a premier, full service biopharmaceutical contract development and manufacturing organization (CDMO), and GE Healthcare Life Sciences (NYSE: GE) have been jointly recognised for the successful design and construction of an advanced single-use biomanufacturing facility as winners of the BioProcess International (BPI) Award for Excellence in Facility Design and/or Retrofit. Gallus BioPharmaceuticals was recently acquired by DPx Holdings B.V. and now operates under the Patheon business unit1.
Gallus and GE Healthcare together designed and built an advanced contract manufacturing facility in just nine months. Utilizing GE Healthcare’s FlexFactory™, a flexible single-use biomanufacturing platform, enabled Gallus to expand its offering to include a “virtual ownership” model in addition to the traditional pay-per-run approach. Virtual ownership gives clients control of dedicated capacity without the outlay of traditional capital investment, as well as the ability to access capacity as needed. During the build, existing office space was stripped back to a shell then converted into a cleanroom environment, including airflow and drainage, into which elements of the FlexFactory platform were installed. Following validation, a total of 23 successful early-phase product bioreactor runs have now been completed for multiple clients over the last 18 months.
Mark W. Bell, chief manufacturing officer of the legacy Gallus business, shared: “The FlexFactory is an important part of our growing business, providing customers with rapid supply of their GMP biotherapeutics. Fast turn-around with a scalable technology from 50L to 2000L built on an integrated platform that includes an all-in-one suite approach to media, buffer, bioreactor and purification technologies is a first for our industry. The customer demand has been so strong that we are already expanding our original FlexFactory capacity. We are delighted that our joint success in this project with GE Healthcare Life Sciences has been recognized by industry experts.”
Parrish Galliher, GE Healthcare Life Sciences, commented: “We are honoured to receive this award alongside Gallus, and it is a pleasure to receive such great recognition from our peers. Widespread adoption of single-use technologies is going to be crucial in the manufacture of proteins for the treatment of diseases such as cancer and rheumatoid arthritis. The winning facility, built around our FlexFactory biomanufacturing platform, is a clear example of how single-use technologies are now playing a major role in supporting the cost-effective development of biotherapeutics.”
Manja Bouman, president of the Patheon biologics business, noted: “We are proud of the Gallus team’s success, and we look forward to continuing to receive achievement awards such as this in the future. We are pleased to expand our biologic drug substance offering to our customers.”
1. For further information on the acquisition review the recent press release, link.
Notes To Editors
About Gallus BioPharmaceuticals
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional development and manufacturing services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records. For additional information, please visit www.gallusbiopharma.com.
Patheon® is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms, including small molecule API and biologic drug substances. Patheon, a business unit of DPx Holdings B.V., encompasses the combined commercial manufacturing capabilities and pharmaceutical product development services, as well as offers a full array of biologic services and pharmaceutical active pharmaceutical ingredients (API) development. Patheon is #1 in product development services, #2 in commercial scale product manufacturing and is #1 in quality. For more information, visit http://www.patheon.com.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
Each company accepts responsibility for the accuracy of statements relating to their respective operations.
Issued for and on behalf of GE Healthcare by Instinctif Partners.
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Tim WatsonAssociate Partner