Early stage formulation development

Ø Study on physical and stability properties of drug substance, such as Tm, Tagg, DLS, and viscosity analysis.

Ø Rapid development of different dosage forms, including vial, PFS and cartridge.

Ø Rapid and high-throughput screening platform to meet the requirement of first-in-human clinical trials.

Formulation screening

Ø DoE-based formulation strategy (Buffer, pH and surfactant).

Ø Stability research under different conditions.

Ø Excipients and primary packaging materials.

Ø Prescription support research: compatibility research of excipients and packaging materials.

Manufacturing process development

Ø Strategic evaluation of suitable manufacturing process.

Ø QbD based optimization of manufacturing process parameters.

Ø Drug product manufacturing process development with scalability and robustness.

Ø Manufacturing process qualification and technology transfer.

Ø Manufacturing process characterization and validation.