News & Press
Edition 1 / March 2021
Highly Potent & Oncology Platform > Key Systematic & Scientific Elements to Safely Handle Your Highly Potent API
Edition 1 / March 2021
Author
Jason Bertola,
Director, Highly Potent & Oncology Platform, CPI
Author
Amy VanAntwerp,
Senior Industrial Hygienist,
CordenPharma Colorado
Highly Potent compound manufacturing at CordenPharma Colorado & Boulder (US) is founded on a systematic & scientific approach to ensure safe handling.
Although regulatory agencies have yet to define what truly makes a compound highly potent, the pharmaceutical industry generally recognizes that a potent compound includes:
In order to safely handle potent and Highly Potent Active Pharmaceutical Ingredients (HPAPIs) and Drug Products, a systematic and scientific approach is needed. A complete containment concept includes hard elements such as engineering controls, and soft elements such as operating procedures and practices.
There is a significant need for quantitative industrial hygiene air & surface data to be developed over the entire time-period that potent compounds are handled, and to verify that the combination of these elements continues to minimize worker exposure & prevent product cross-contamination. This requires employing compound-specific data, in addition to surrogate data for verifying controls. The following demonstrates how CordenPharma Colorado and CordenPharma Boulder effectively applied potent compound safety elements into their business to meet growing demand for the safe manufacture of these potent APIs.
The following section provides only a few of the basic principles around safe potent compound handling, and the ways in which CordenPharma Colorado & Boulder successfully implemented them.
Prior to bidding a new process into the CordenPharma Colorado facility, an evaluation is first performed with a qualitative & quantitative assessment of the product from an occupational health standpoint. CordenPharma regularly engages toxicology experts for these qualitative & quantitative assessments and training for new employees.
Engineering controls represent the hard element of the containment program. CordenPharma Colorado utilizes a variety of containment systems, including hard-sided and flexible isolators, drum containment systems with powder transfer systems, continuous liners, and local exhaust ventilation, among others.
The soft aspects, such as a containment culture, are also vital to the success of the program. Individuals at all levels of the organization must understand their personal roles and responsibilities in safely containing HPAPIs. Executive management must also be committed to leading the program – this means ensuring that appropriate resources are provided for containment systems, from design and ongoing maintenance to monitoring, and that employees are accountable for themselves and their co-workers to ensure that containment systems are used properly. The end-user operators must also feel empowered to continuously identify and implement improvements to containment systems. Supporting this containment culture is a top-down process, where site-wide goals are set at the management level to maintain and improve containment and HPAPI handling capabilities, while at the operations level safety observations are openly discussed with management.
Based on the track record of success in CordenPharma Colorado and CordenPharma Boulder, a systemic and scientific approach is needed to safely handle HPAPIs and Drug Products. This combines hard elements (containment, engineering control) and soft elements (procedures, practices), which when integrated, prove to produce enhanced and repeatable containment for specific installations, and vital scientific principles for creating and maintaining a robust industrial hygiene program.
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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.
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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.
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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.
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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.
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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.
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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.