News & Press
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.