OSD
Analytical testing is an essential part of pharmaceutical development and manufacturing, providing essential evidence of the safety and efficacy of a drug product for patient use. Throughout the development and manufacturing pipeline, these analytics provide crucial insights into the product’s safety, potency, efficacy and quality to comply with regulatory standards.
Choosing the right analytic technique is key and must be tailored to the specific molecule and its stage in the development and manufacturing process. As well as producing high-quality and high-yield products, these strategic analytics help highlight opportunities for process optimisation and are essential elements of an investigational new drug filing application.
But what are the six steps to achieving analytical success?
- Literature search: Explore published analytical works to find tests that provide the required information for your drug substance or product.
- Characterising the compound: Employ standard techniques to fully characterise your molecule, including its chemical structure, pKa, solubility and formulation.
- Selecting the analytical technique: Choose an appropriate method based on the desired characteristic or functional information of your molecule, such as liquid chromatography (HPLC/UPLC with UV/RI/ELSD) or MS-based techniques (LC-MS, ICP-MS).
- Defining the analytical target profile: Determine method parameters such as system suitability criteria (sensitivity, selectivity, precision), peak resolution, interference limits, run time, detection and quantification limits, robustness and reproducibility.
- Identifying the critical method parameters: Conduct a risk assessment of instruments, materials, methods, measurements and laboratory environment to identify potential areas of human error. These parameters can significantly affect the performance, accuracy and reliability of your method, requiring optimisation for your specific molecule and ensuring the validity of its analytical results.
- Method verification and finalisation: Validate optimised analytics through specificity, solution stability, accuracy, method precision and robustness testing. This will confirm the reliability, reproducibility and regulatory compliance of your method.
To find out more about how to achieve these steps effectively, read the full piece in Contract Pharma where our Vice President of Analytical Development Ramesh Jagadeesan, Ph.D., shares his expert insights into leveraging analytics for drug product success.