News & Press
November 25, 2020
Press Release > CordenPharma Colorado Expands US GMP Peptide Manufacturing
In order to accommodate the continuous growth and evolution of the peptide therapeutic market, CordenPharma Colorado completed earlier this year an expansion of its Solid-Phase Peptide Synthesis manufacturing capacity with the addition of an extra-large 3’000 L SPPS vessel. Our strategy is to anticipate expanding US market needs by investing in new manufacturing techniques to constantly improve the productivity of our peptide assets – in particular via the deployment of innovative Process Analytical Technology (PAT).
Now with even greater demand to rapidly respond to our partners’ accelerated programs, a long-term expansion initiative was approved to further increase our flexibility, efficiency and ultimately, cost-effective production. For the first phase of this commitment, customized automated synthesizer production lines will be installed supporting fast and efficient GMP manufacturing. This infrastructure will further strengthen the existing manufacturing of Peptides in the low to mid-kg scale range by complementing the current state-of-the art large-scale manufacturing capabilities at CordenPharma Colorado.
In addition, special emphasis on design will further harmonize our network and enable a seamless Tech Transfer process from our Peptide Development Centre of Excellence in Frankfurt, Germany, due to an exact mirroring of its new non-GMP production lines that are currently being installed.
The new expansion initiative will be augmented by our integrated supply of peptide APIs to Injectable Drug Products from CordenPharma Caponago, our facility in Italy dedicated to the Formulation Development and Drug Product manufacturing of sterile injectables. By leveraging our global facility network, this vertical supply model spans the complete cGMP supply chain from regulated raw materials, intermediates, and APIs, to commercial-scale Drug Product manufacturing, finished dosage formulation, clinical trial services, & pharma logistics. This fully integrated peptide solution uniquely positions CordenPharma as the only CDMO to truly offer integrated peptides services in the industry.
Organized under the Peptides, Lipids & Carbohydrates Platform, CordenPharma is a recognized leader in Peptide supply with over 110 years of cumulative Peptide experience across our global facility network in Europe and the US. Our experience gained in both solid-phase and liquid-phase manufacturing allows for a high level of response to growing local demand at the country and community level, particularly during the recent COVID-19 pandemic.
With approximately 350 employees, CordenPharma Colorado has grown a strong focus in the development & manufacturing of APIs from laboratory-scale to commercialization at ton-scale, due to their unique large-scale SPPS capabilities. The purification of the final peptide is performed at any scale using column chromatography, with columns ranging from 5 cm to 100 cm. To avoid the tedious and poor productivity of the final isolation step by lyophilization, their development team has gained an unmatched expertise in the isolation of peptides by precipitation that has been successfully transferred to production in a number of commercial products. The site has a long record of accomplishment in the large-scale manufacturing of Peptides, where all potencies, including picogram levels, are managed.
GMP Peptide Manufacturing at CordenPharma Colorado (US)
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#CordenPharmaBergamo
Celebrations included a garden party with German-themed breakfast, lunch or dinner buffets, 15 Year custom cakes and gifts distributed to all employees, along with a speech from Managing Director Luca Porcu and VP of Platform Management & Marketing Stephen Houldsworth.
#CordenPharmaSwitzerland
Celebrations included an introduction of our core values, followed by playful games to implement them, distribution of 15 year bags, food and a live band in a garden party. Employees heard from Managing Director Dr. Juerg Burger and VP of Human Resources Stefanie Gerber.
#CordenPharmaPlankstadt
Celebrations were split into 3 groups to cover all shifts and included a festive room with a 3 course buffet meal, 15 Year custom gift bags with locally-brewed beer, and a welcome speech by Site Business Development Christina Simons and CEO Dr. Michael Quirmbach.
#CordenPharmaFrankfurt
Celebrations included a garden party with food trucks, table games, a pub quiz with team prizes, instant cameras for a photo collage, and 15 Year gifts. Guests included the CPI Global Compliance Team, Allessa GmbH, Weylchem Innotec GmbH, and Walter Krebs GmbH, with speeches by Head of Operations Dr. Karsten Meyenberg and CFO Heiko Serwe.
#CordenPharmaChenôve
Celebrations included a garden party with a “Burgundy” aperitif dinner, food trucks for lunch, a fun photo booth for taking 15 Year souvenirs, and speeches by Managing Director Yves Michon and CordenPharma Chief Quality & Compliance Officer Will Cashin.
#CordenPharmaCaponago
Celebrations continued 4 times throughout the day & night to cover all shifts, and included a multi-course German lunch or dinner with brezel, speeches by Managing Director Fabrizio Fiordigiglio and VP of Sales Dr. Mimoun Ayoub, followed by a festive garden gazebo for the 15 Year gift distribution of Prosecco and backpacks.
#CordenPharmaBrussels
Celebrations included a boat ride to Brussels City Center, followed by 3 groups taking guided bike or walking tours of secret places along the canal or the Tour & Taxis building. The party finished with a BBQ dinner and speeches from Managing Director Dr. Jean-Luc Dewez and VP General Counsel Nicolas Reischer.
#CordenPharmaBoulder #CordenPharmaColorado
Celebrations included a garden party with a festive banquet of foods from Italy, Germany, France, & US, games, marshmallow roasting, custom beer steins and other 15 Year gifts, and balloons stuffed with prizes. All employees then heard a speech from Managing Director Brian McCudden and COO Dr. Lee Newton.
Brittany Hayes joined CordenPharma as Director, Global Highly Potent & Oncology Platform in October 2021, bringing over 20 years of extensive experience in the areas of contract manufacturing (Drug Substance & Drug Product), pharmaceutical and API development, business development, contract management, and organic chemistry.
Prior to joining CordenPharma, Brittany held leadership positions at various Contract Development & Manufacturing Organizations (CDMOs) including Recro, Regis Technologies, DSM/Patheon/Thermo Fisher, Formex, Ricerca, and Azopharma. Most recently, Brittany was Applied Technology Director at Recro, where she was responsible for managing the proposal evaluations and development team, providing technical support to the BD team, creating training for new service offerings, and enhancing new client onboarding & knowledge transfer by liaising with business development executives, technical operations personnel, and project managers. Brittany excels at driving technical decision-making for successful pharmaceutical product development.
Brittany earned her Ph.D. in organic chemistry from Wake Forest University (Winston-Salem, NC) and her B.S. degree in Chemistry from Emory University (Atlanta, GA). She also was an American Heart Association postdoctoral fellow at the University of Illinois at Chicago, Department of Medicinal Chemistry & Pharmacognosy. Brittany has been an active member of the American Chemical Society since 1995.