R&D and Production
Formulation Development
Services
● High-throughput screening of formulation buffer systems and excipients
● Identification of protein degradation pathways through stress testing experiments
● Comparative analysis of different formulation recipes using Design of Experiments (DOE) design
● Selection, compatibility studies, and integrity testing of pharmaceutical container systems (packaging materials, containers, etc.)
● Development of formulation and filling process methodologies
● Process development for pre-filled systems
● Development of freeze-dried (lyophilization) formulations and associated processes
● Design and execution of stability studies (long-term, accelerated, stress, compatibility, etc.) in compliance with ICH guidelines
● Technical transfer and process scale-up support for GMP-compliant production and filling operations
