Successful drug product development underpins all commercial manufacturing activities. At Adragos, our Research and Development (R&D) department brings extensive experience in developing a wide range of dosage forms, translating a client’s initial concept into a viable, manufacturable, and effective product.
The process addresses fundamental questions of composition, manufacturing methodology, and analytical performance testing. It requires the integration of concepts from pharmacy, chemistry, material sciences, biopharmaceutics, and engineering. This fosters a collaborative partnership with subject matter experts across our organisation, including Regulatory Affairs, Quality Assurance, Quality Control, and Technology Transfer teams.
Integrating Science and Strategy in Dosage Form Development
The development process comprises several distinct phases, each varying in complexity based on the specific nature of the product. Our initial task is to understand the client’s vision for the product’s appearance and behaviour and then determine how it can be scientifically and technically achieved.
Establishing the Knowledge Space
The journey begins with establishing the knowledge space around the therapeutic molecule. We identify interdependencies between the molecule’s properties and key performance aspects such as bioavailability, stability, and manufacturability. This pharmaceutical formulation development stage lays a strong foundation for designing meaningful screening and optimisation experiments. These experiments are crucial for determining effective values and ranges for formulation and process variables, guiding the development pathway toward a robust drug product.
The Role of Analytical Method Development
In parallel with formulation activities, analytical method development is of equal importance. A robust analytical framework is essential to ensure proper characterisation and quality control of the product throughout its development and its entire commercial lifecycle.
Applying Quality by Design (QbD) for Process Robustness
Our work is conducted in accordance with the principles of Quality by Design (QbD), ensuring product quality is built-in from early development through the entire product lifecycle. Aligned with the QbD concept, we gain a thorough understanding of the critical aspects of the product, including a clear identification of potential risks.
Risk Assessment and Statistical Experimental Design
This understanding allows us to create processes that effectively mitigate and control these risks. We apply core QbD tools, including risk assessment methodologies and statistical Design of Experiments (DoE), to identify the most influential factors and their interactions. This approach enables us to streamline the development process by prioritising those factors that require further investigation and optimisation. The result is a robust and well-understood product and manufacturing process.
Seamless Technology Transfer in Pharma Manufacturing
The development process at Adragos extends to process technology transfer in pharma manufacturing, facilitating a smooth transition from R&D to industrial scale. In collaboration with the process engineering team, whether within the Adragos Group or with external partners, we ensure the effective transfer of knowledge gained during development and actively support the large-scale realisation of the product.
Data-Driven Scale-Up and Process Optimisation
As we progress to larger batch sizes, this careful foundational work provides valuable insights into the product’s sensitivities relative to various upscaling factors. Any necessary process parameter adjustments are made based on data-driven decisions. This optimises the manufacturing process to ensure consistent, high-quality, and efficient production, fulfilling the ultimate goal of our dosage form development programme.
