Long-term stability test and accelerated stability test were carried out with reference to NMPA guidelines, and the formulations, key excipients, packaging materials and containers were inspected and screened. Through the optimization study of process parameters, the range of production parameters to meet product quality requirements is determined. Confirmation of optimal formulation composition; evaluation of key parameters and confirmation of key process parameters. Establish the operating range of process parameters, determine the durability of the process, and determine sufficient process control points, etc., to lay the foundation for the production of the product. Now we have a clean pilot plant in line with GMP standards, equipped with independently verified air conditioning systems and pure water systems, a complete GMP document management system and a professional formulation team, which can ensure the production of formulation products with stable processes.
Biological product preparation process services:
Process Optimization
Quality and Stability Studies
Packaging and storage conditions
IND filing document writing