What changed?

The Impacts and Benefits

Impact for the Company

Compression-induced polymorphic transformations in active pharmaceutical ingredients (APIs) prevent consistent product quality and efficient manufacturing processes. This is due to the effect of multiple polymorphs in the final drug product. Polymorphism, where an API can exist in multiple crystalline forms, can significantly impact drug performance by altering solubility, bioavailability, and stability in a drug product. Greater control of the polymorphic form during tabletting processes and better characterisation techniques will lead to more efficient scale-up from R&D to full-scale manufacturing. Overall better management of potential polymorphic transformations will improve product consistency, reduces costs, speed up development, and ensure regulatory compliance, ultimately providing a competitive advantage to the company in the pharmaceutical market.

Impacts for the Academic Team 

Developing a workflow to manage compression-induced polymorphic transformations of APIs greatly benefits academic research teams by improving efficiency, data quality, and collaboration. A structured approach streamlines experimentation, allowing researchers to follow systematic protocols that reduce trial-and-error efforts, resulting in more reliable, reproducible data. Integrating advanced analytical tools like X-ray diffraction (XRD) and Raman spectroscopy into the workflow enables precise detection and analysis of polymorphic changes, providing deeper insights into how factors like pressure and temperature affect API behaviour. This enhanced data collection supports more accurate research findings, which are crucial for advancing pharmaceutical science. Additionally, a well-documented workflow fosters collaboration by making it easier to share methods and results with other researchers and industry partners, opening opportunities for interdisciplinary projects and funding. It also serves as a valuable educational tool, teaching students and early-career researchers best practices in experimental design and process control. Ultimately, a structured workflow enhances research productivity, facilitates collaboration, and increases the potential for securing grants and high-impact publications.

Impacts for the KTP Associate 

Developing a workflow significantly enhances an associate's learning and professional development by providing a structured framework for conducting research. This structured approach helps associates grasp complex concepts and methodologies more easily. As associate engages with the workflow, they acquire practical skills in various techniques and tools, fostering hands-on experience essential for their future careers. A defined workflow encourages critical thinking and problem-solving, enabling the KTP associate to anticipate challenges and make informed decisions based on data. It also emphasizes the importance of documentation and clear communication of methods and findings, which are crucial for reproducibility and collaboration. Moreover, working within a workflow facilitates interdisciplinary collaboration, broadening associates’ knowledge and enhancing teamwork skills. Regular checkpoints for evaluation and feedback promote a culture of continuous improvement, encouraging associates to refine their skills over time. Ultimately, developing competencies through a structured workflow positions associates for greater career advancement opportunities and prepares them for future challenges in their professional journeys.