Analytical Methods

Due to the complexity of the drug structure, it is necessary to provide accurate and stable test results through suitable analytical methods. In addition, conducting long-term product quality characteristics tracking is essential to make a correct, comprehensive judgment on drug quality.

Based on the concept of QbD (Quality by Design), Mycenax establishes the product QTPP (Quality Target Products Profile) to facilitate the communication with regulatory agencies by strong quality data. In the process of new drug development, it is important to maintain the consistency of product quality through characteristic analysis or comparative analysis. For biosimilar drugs, the product quality of the developed product and the original drug will be confirmed through similarity analysis.

We aim to provide customers with a stable and accurate analysis method.

By using the risk assessment tool, we can identify the more critical experimental steps or parameters scientifically and logically. The appropriate operating parameter range for each method will be further established by a series of experimental designs. The developed testing method will be qualified and validated at different stages according to the product development life cycle to ensure the reliability of the testing data which will then be used in product release inspection.

Mycenax’s lot release testing program offers an extensive range of high-quality analytical test methods for each stage of product manufacturing and for testing in accordance with GMP and global regulatory requirements.

For product stability study, Mycenax can design experiments such as long-term stability tests, accelerated tests, stress tests, photostress tests in line with ICH guidelines.