By Argyro Stappa, Head of R&D, Athens.
The R&D department here at Adragos in Athens underpins all the company’s activities in drug product development. Our team brings extensive experience and expertise in developing a wide range of dosage forms.
We take the client’s idea about they want the product to look and behave, and set about working out how this can be achieved. We work through questions such as: What is its composition? How is it best manufactured? And how should its performance be tested analytically?
The development process comprises several distinct phases, each of which varies in complexity based on the specific nature of the product. Our work requires the integration of various concepts from pharmacy, chemistry, material sciences, biopharmaceutics and engineering, fostering a collaborative partnership with subject matter experts from other departments here at Adragos, including Regulatory Affairs, Quality Assurance, Quality Control, and Technology Transfer.
We work in accordance with the principles of Quality by Design, ensuring that product quality is in place at all stages – 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 any potential risks. This understanding allows us to create processes that effectively mitigate and control these risks, leading to robust and well-understood products and processes.
The product development phase begins with the establishment of the knowledge space around the therapeutic agent/molecule. Next, we identify any interdependencies between the molecule’s properties and key performance aspects such as bioavailability, stability, and manufacturability. By linking the intrinsic properties of the molecule with the desired performance characteristics of the drug product, a strong foundation is laid that allows us to design meaningful experiments. These experiments – both screening and optimization – are crucial for determining effective values and ranges for formulation and process variables. They guide the development process toward robust drug products.
In parallel with these activities, analytical method development is equally important. This will ensure the proper characterization and quality control of the product throughout its lifecycle.
Here at Adragos, we apply QbD tools, including risk assessment methodologies and statistical experimental design, to identity most influential factors and their interactions. This approach enables us to steamline the development process by prioritizing those factors that most need further investigation and optimisation.
The development process at Adragos extends to process technology transfer, facilitating the 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 realization of the product.
As we move to larger batches, our careful work gives us valuable insights into the product’s sensitivities relative to various upscaling factors. Any necessary process parameter adjustments are made based on data-driven decisions, optimizing the manufacturing process to ensure consistent, high-quality, and efficient production of the drug product.
