Late phase development of biologics remains the lengthiest phase (almost double the time of early phase) and the most cost-intensive part of drug development (multiple times the cost of reaching first in human). This is determined by the essential need to accomplish the development phase with a product of maximum end to end stability, from manufacturing to final patient administration, in alignment with the complexity of country specific regulations in preparation for market authorization. Therefore, late phase development requires a holistic development strategy driven by a well-defined target product profile while keeping the patient and final market presentation in mind.
Although the final formulation is typically selected prior to pivotal clinical trials, further aspects around formulation robustness, identification of critical quality attributes and in-use stability testing for definition and alignment of patient administration procedures, in-use holding times and test materials are key elements of late phase development. The drug product manufacturing process needs to be systematically characterized prior to validation and commercialization, following a quality risk management approach to assess operating ranges of manufacturing unit operations, and identifying critical process parameters.
In case other primary packaging than vials are used, or if it is introduced as part of life cycle management, even further requirements of combination product development need to be considered on top and must be an additional integrated part of the holistic development strategy. The design control process, comprising risk assessments, design parameters, design verification & validation as well as process design studies, needs to be aligned with the development and manufacturing strategy and usually is a cross-functional activity.
Finally, a systematic and structured process technology transfer of the drug product manufacturing process from development to commercial manufacturing is a pre-requisite for a successful launch of a new drug product. This webinar aims to provide you with an overview of the complex path to a successful product launch, with experts from each of the areas outlined above.
Key Learning Objectives:
- Late stage Drug product development is a cross functional holistic approach getting the product ready for commercialization
- The ultimate purpose of pharmaceutical development is to assure end to end robustness of the drug product
- Combination products follow different requirements which, however, needs to be an integrated part of Drug product development