DRUG PRODUCTS

CordenPharma’s pharmaceutical Drug Product Development covers the entire process from concept to clinical and commercial manufacturing.

Our Drug Product development starts with the screening of suitable formulations and processes to best meet the defined target product profile. These formulations / processes are analysed to identify the critical parameters potentially impacting the quality of the required defined target profile. Both formulations and processes are challenged and optimized to ensure that the Drug Product can be manufactured by a robust and efficient process according to 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 solid dosage 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 and oncology non-cytotoxic drug compounds we perform all development activities in dedicated areas suitable to handle highly potent compounds. In these areas 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 can be 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, conduct the necessary stability studies according to ICH requirements and validate 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 substances in appropriate facilities. Our area also covers sterile forms such as solutions, both lyophilised and emulsions, as well as our selected project teams to support the entire process from the start of development until completion.