News & Press
November 30, 2021
Press Release > CordenPharma to Invest €9.7 Million in Highly Potent Oral Solid Dosage at CordenPharma Plankstadt.
CordenPharma, a full-service Contract Development Manufacturing Organization (CDMO) of Active Pharmaceutical Ingredients (APIs), Excipients, Drug Products & Packaging services, is pleased to announce the investment of €9.7 Million into the design and installment of a new GMP Clinical Trial Development (CTD) facility for the manufacturing of oral solid dosage Drug Products at our CordenPharma Plankstadt facility located near Heidelberg, Germany.
From early-stage development to full commercial scale, CordenPharma Plankstadt is our Centre of Excellence for the Development & Manufacturing of Highly Potent Oral Solid Drug Products for compounds that have an OEL level < 1 µg/m3. We specialize in the safe handling of Highly Potent APIs and Drug Products, offering a full range of services for pharmaceutical development including manufacturing, packaging, and pharma-logistics.
The installment of the new CTD facility at CordenPharma Plankstadt is a response to our customers’ demands and the recognition of gaps in scale, formulation development technologies for insoluble APIs, and manufacturing of capsule products. Joining three other CTD facilities (CTD 1: 1-5 kg GMP; CTD 2: 5-20 kg GMP; CTD 3: non-GMP), CTD 4 will bridge the scale gap between CTD 2 and the two Production Facilities (PF 1 and PF 2) to manufacture GMP batches up to 50 kg. CTD 4 will be equipped with all of the key oral solid dosage manufacturing needs including blending, granulation (high shear, fluid bed, roller compaction), compression, and coating. Investments in high potency filling equipment (powders, pellets, mini-tablets) into capsules, hot melt extrusion (HME), and the ability to operate with organic solvents are also being added. The facility will be designed with multi-product capability, allowing multiple projects to run in parallel. Work has recently started in the fourth quarter of 2021, with a targeted completion date in the third quarter of 2022.
CordenPharma’s Highly Potent Oral Solid Drug Product Centre of Excellence in CordenPharma Plankstadt (DE).
“This is an extremely important and significant investment for CordenPharma Plankstadt. The new CTD 4 facility will bridge the gap between our small-scale GMP and larger commercial production facilities. It also expands our capabilities beyond coated tablets with the addition of contained-capsule filling equipment,” states Dr. Lutz Henkel, Managing Director of CordenPharma Plankstadt. “CordenPharma’s goal is to be the leading CDMO for the development and manufacturing of Highly Potent & Oncology solid dosage forms. Adding Hot Melt Extrusion to our toolbox allows us to help more customers that have solubility-limited APIs. We are excited about this investment in Plankstadt, as it strengthens our core capabilities and expands our service offerings,” adds Dr. Brittany Hayes, Director of CordenPharma’s Global Highly Potent & Oncology Platform.
“This is an extremely important and significant investment for CordenPharma Plankstadt. The new CTD 4 facility will bridge the gap between our small-scale GMP and larger commercial production facilities. It also expands our capabilities beyond coated tablets with the addition of contained-capsule filling equipment,” states Dr. Lutz Henkel, Managing Director of CordenPharma Plankstadt.
“CordenPharma’s goal is to be the leading CDMO for the development and manufacturing of Highly Potent & Oncology solid dosage forms. Adding Hot Melt Extrusion to our toolbox allows us to help more customers that have solubility-limited APIs. We are excited about this investment in Plankstadt, as it strengthens our core capabilities and expands our service offerings,” adds Dr. Brittany Hayes, Director of CordenPharma’s Global Highly Potent & Oncology Platform.
The investment in CordenPharma Plankstadt is the latest of several announced investments made by CordenPharma during 2021, where further capacity expansion and capabilities have been installed in CordenPharma Colorado and CordenPharma Chenôve to meet growing customer demands.
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#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.
#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.
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.