CordenPharma’s pharmaceutical Drug Product Development covers the entire process from the product idea to production of the registration file ready for submission.

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 optimised to ensure that the Drug Product can be manufactured by a robust and efficient process according to DOE 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.

Dedicated project managers supported by a project team with members from all relevant departments will manage your project from the start and ensure consistent coordination, communication and alignment of progress throughout all project phases.

Project goals, risks, agreed mitigation approaches and deliverables are specified together with our customers during kick-off and described in a detailed project specification. Project plans are generated by the project managers and tracked vigorously to ensure that we will always deliver the highest quality to our customers within the agreed timelines.

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.

For highly potent (oncological non-cytotoxic) drug compounds we perform all development activities in a dedicated area suitable to handle OEB4 compounds using PPE. In this area solid dosage forms can be manufactured by high shear granulation, fluid bed granulation, direct compression, granule and tablet coating, and encapsulation at a batch size of 100 g to several kilograms.

For highly potent (oncological cytotoxic) drug compounds we perform all development activities in a dedicated area with scale up in a GMP area suitable to handle OEB5 compounds using PPE. In this area solid dosage forms can be manufactured by granulation, direct compression, and encapsulation with variable batch sizes.

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 1kg – 50 kg for clinical phase I - III studies. Furthermore, sourcing and blinding of comparators and clinical trial packaging can also be included as part of our pharmaceutical development services. Oral solid dosage forms for penicillin and cefalosporin have separated facilities.

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 such as hormones, cytostatics, and ß-lactams in appropriate facilities. Our area also covers sterile forms such as solutions, lyofilised and emulsions as well as our selected project teams to support the entire process from the start of development until completion.

CordenPharma’s capabilities to support our customers in Drug Product Development include expertise in:
  • Sterile emulsions
  • Sterile solutions
  • Lyofilised oncology
  • Pre-filled syringes
  • Clinical trial preparations
  • Formulation development
    • Oncological solid forms (capsules and tablets)
    • Oncological parenteral liquid forms (up to OEB 5)
    • Oncological parenteral lyofilised forms (up to OEB 5)
    • ß-lactams in solid and sterile powder forms
    • Hormones and hormone blockers in solid forms (up to OEB 4/5)
    • Organic solvent granulation for highly potent (non-cytotoxic) compounds
    • Clinical trial medication (also for highly potent compounds)
    • Modified release tablets, two-layer tablets
    • Capsule filling with different components (e.g. granules + tablets)
    • Stick packs