Development of Formulation Process

Development and qualification of drug formulation process are required for IND application. The formulation is essential and critical for drug efficacy evaluation. 

Drug formulation development is performed using efficient design of experiments (DoE), customer-oriented compliant excipients.

1. The protein stability is efficiently predicted by optical techniques such as DLS and SLS. 

2. Based on the QbD concept, the experimental design of DoE is preferentially applied to drug formulation development. 

3. Actively communication with customers is made for formulation qualification, with priority given to the use of customer-oriented sources of excipients. 

4. Excipient COAs are reviewed according to appropriate pharmacopeias to ensure the excipients are compliant. 

Service Highlights

1. Comprehensive Study of Quality

• A comprehensive and multi-dimensional study includes appearance, pH, SEC, CE-SDS, CEX, insoluble particles, Tm value, and activity.

• The latest regulations in Chinese Pharmacopoeia (2020 Edition), ICH guidelines, USP, etc., are applied to manage the risks during application.

• A comprehensive characterization is conducted for particle size, PDI dispersion coefficient, sub- visible particles, etc., to ensure the effectiveness and safety of post-marketing formulations.

2. State-of-the-Art Instruments and Equipment

• International mainstream first-line equipment, such as constant temperature incubators, light incubators, low-temperature shakers, and freezers, is used for protein stability study, which can be put into use only qualified after relevant validations.

• The equipment has been subjected to relevant regulatory validations and performance qualifications to ensure that the data can support the application.

• The equipment is regularly maintained and calibrated to ensure accurate and reliable data are outputted.

3. Customer-Oriented

• Raw materials in compliance and excipients designated or suggested by customers are used for drug formulation.

• Customized study protocol is provided to customers.

• A mature modular platform, advanced testing instruments and equipment, and simultaneous. investigation of multiple test indicators boost the early application of projects.