News & Press
October 31, 2019
Article > Strengths & Strategies: CordenPharma's New CEO Talks About His Company
by Dr. Michael Quirmbach, Chief Executive Officer & President, CordenPharma
PHARMAnetwork, No. 43 / October 2019
CordenPharma’s newly appointed CEO & President, Dr. Michael Quirmbach, discusses the history and strategy of CordenPharma’s formation by ICIG, the future of CordenPharma, as well as a broad range of strengths & technical capabilities in both API & Drug Product manufacturing. He particularly focuses on the key areas of Highly Potent & Oncology APIs & Drug Products, Injectable Drug Products and small to large-scale Peptide manufacturing. He then highlights CordenPharma’s unique full-service supply chain offering, which brings clear benefits to customers in the pharma industry.
Dr. Quirmbach (CordenPharma):
CordenPharma’s pharmaceutical Drug Product development covers the entire process from concept to clinical & commercial manufacturing – both for Oral Solid Dosage (OSD) in CordenPharma Plankstadt (DE), and Injectables in CordenPharma Caponago (IT) and CordenPharma Latina (IT).
In general, our drug product development starts with the screening of suitable formulations and processes that best meet the defined target product profile. These formulations / processes are then analyzed to identify critical parameters potentially impacting the quality of the required defined target profile. Both formulations & processes are challenged and optimized to ensure that the Drug Product will be manufactured by a robust and efficient process in accordance to Quality by Design (QbD) concepts.
During scale-up, critical parameters are established and verified with appropriate control strategies to ensure that quality attributes are consistently met for validation during routine manufacturing. Besides our dedication to quality, we also focus on optimization of process ranges and robustness in order to improve manufacturing efficiency and reliability within a continuous improvement process.
For OSD forms we start at lab-scale batch sizes of approximately 100 g – 5 kg for all of our technologies, which can then be scaled up to pilot-scale and / or commercial-scale batch sizes depending on exposure level. In particular, as it relates to Highly Potent & Oncology non-cytotoxic drug compounds, we perform all development activities in dedicated areas suitable to handle OEB 4 compounds, where solid dosage forms can be manufactured by high shear granulation, fluid bed granulation, direct compression, granule & tablet coating, and encapsulation at batch sizes of 100 g to several kilograms. Furthermore, Oral Solid Dosage forms for both non-potent and highly potent drug compounds are manufactured in separate areas under cGMP. Thus, we offer bulk manufacturing from 1 kg – 50 kg for clinical phase I – III studies.
In parallel to formulation and process development, CordenPharma draws upon combined resources across multiple cGMP facilities to develop the analytical methods for drug compounds, excipients and drug products, conducts the necessary stability studies according to ICH requirements, and validates all methods and processes. For commercial- scale production, we manage and perform the transfer of methods and processes from the donor site, the scale-up of the process to the appropriate level and the full validation program for filing.
CordenPharma’s expert development teams work on projects for solid dosage forms with Highly Potent & Oncology substances such as hormones, cytotoxics and cytostatics in appropriate facilities. Our area also covers sterile forms such as lyophilised & emulsion solutions, where selected project teams support the entire process from the start of development until completion.
Sterile drug product manufacturing requires dedicated and specialized capabilities which are in compliance with FDA aseptic guidance and EMA regulatory requirements. CordenPharma has a long track record of experience in manufacturing parenteral sterile solutions and emulsions in different pharmaceutical forms such as ampoules, vials and pre-filled syringes. Our facilities and equipment design, combined with experienced and trained personnel, are pivotal for success in sterile manufacturing. Currently, two sites of the CordenPharma network are involved in sterile liquid drug product manufacturing – CordenPharma Caponago and CordenPharma Latina, both in Italy.
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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.