Recognition for design and build of advanced single-use biomanufacturing facility in just nine months
St. Louis, Missouri, USA and Chalfont St Giles, UK – 3 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 by being shortlisted for 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 have together designed and built an advanced contract manufacturing facility in just nine months. Utilizing GE Healthcare’s FlexFactory™, a flexible single-use biomanufacturing platform, has 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: "Our customers are looking to rapidly develop new biotherapeutics and the flexibility and speed of set-up provided by single-use technologies are crucial for us in helping them achieve this. Putting the FlexFactory biomanufacturing platform at the heart of our new facility has enabled us to offer a wider range of cost-effective and flexible solutions to our clients. We are delighted that our joint success in this project has been recognized by industry experts."
Parrish Galliher, GE Healthcare Life Sciences, commented: "We are delighted to be honoured by our industry peers for our project with Gallus. We view the introduction of single-use technologies as playing a major role in the manufacture of biotherapeutic proteins for the treatment of diseases such as cancer and rheumatoid arthritis, as well as the new generation of vaccines. Being nominated as a finalist with Gallus for excellence in facility design is a great endorsement of the fact that our FlexFactory biomanufacturing platform, and the single-use technologies contained within, can support the cost-effective development of biotherapeutics."
Manja Bouman, president of the Patheon BIO business, noted: "We are proud of the Gallus team’s accomplishments with this award and look forward to continuing the success that the team has already achieved. Together 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.
- ENDS -
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.
About Patheon®
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.
For more information please contact:
Gallus BioPharmaceuticals
Claire Ruzicka, Senior Marketing Manager
T +1 314 733 3814
E Claire.Ruzicka@gallusbiopharma.com
@GallusBio
Patheon
T +1 919 226 3200
media@patheon.com
GE Healthcare
Dr Val Jones, Media Relations Manager
T +44 7917 175 192
E val.jones@ge.com
@GEHealthcare
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St. Louis, Missouri, USA and Chalfont St Giles, UK – 3 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 by being shortlisted for 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 have together designed and built an advanced contract manufacturing facility in just nine months. Utilizing GE Healthcare’s FlexFactory™, a flexible single-use biomanufacturing platform, has 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: "Our customers are looking to rapidly develop new biotherapeutics and the flexibility and speed of set-up provided by single-use technologies are crucial for us in helping them achieve this. Putting the FlexFactory biomanufacturing platform at the heart of our new facility has enabled us to offer a wider range of cost-effective and flexible solutions to our clients. We are delighted that our joint success in this project has been recognized by industry experts."
Parrish Galliher, GE Healthcare Life Sciences, commented: "We are delighted to be honoured by our industry peers for our project with Gallus. We view the introduction of single-use technologies as playing a major role in the manufacture of biotherapeutic proteins for the treatment of diseases such as cancer and rheumatoid arthritis, as well as the new generation of vaccines. Being nominated as a finalist with Gallus for excellence in facility design is a great endorsement of the fact that our FlexFactory biomanufacturing platform, and the single-use technologies contained within, can support the cost-effective development of biotherapeutics."
Manja Bouman, president of the Patheon BIO business, noted: "We are proud of the Gallus team’s accomplishments with this award and look forward to continuing the success that the team has already achieved. Together 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.
- ENDS -
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.
About Patheon®
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.
For more information please contact:
Gallus BioPharmaceuticals
Claire Ruzicka, Senior Marketing Manager
T +1 314 733 3814
E Claire.Ruzicka@gallusbiopharma.com
@GallusBio
Patheon
T +1 919 226 3200
media@patheon.com
GE Healthcare
Dr Val Jones, Media Relations Manager
T +44 7917 175 192
E val.jones@ge.com
@GEHealthcare
Help employers find you! Check out all the jobs and post your resume.
