3P - Tech Transfer/ Scale-Up and Non-GMP Manufacturing Services

We prepare draft documentation to establish upstream and downstream unit operations during the project’s development stage, which is refined further during the scale-up activities and non-GMP batches. Typically, we perform one engineering run to evaluate and confirm that the process is robust and under control. Material generated during the engineering batch can be used as a reference standard and/or for stability studies. We recommend that the product obtained is used for formulation screening and placed on stability testing to understand the product’s shelf-life and its behaviour under different storage conditions (accelerated and stress conditions).