We work closely with partners throughout their complete parenteral drug development program. As an FDA-approved CDMO, we ensure that the final process is scalable and successfully transfers to a cGMP–compliant commercial manufacturing process. With decades producing highly viscous sodium hyaluronate formulations, we offer expertise to those developing unique products that are challenging to formulate, sterile filter, and aseptically fill.
Our Process Development Approach:
Our QbD (Quality by Design) approach to development drives toward a manufacturing process that is effective, efficient, and validated. And, with a team dedicated to handling each new project, continuity is maintained from development through to clinical and commercial manufacturing. Depending on your formulation needs and critical quality attributes (CQA), our expert technical team will test a range of Critical Process Parameters (CPP) and design equipment to meet the project objectives. CQAs are evaluated, established and monitored through in-process and final product testing to ensure they meet appropriate specifications and release criteria.
Process Development Capabilities:
Formulation:
- Formulation optimization
- Aseptic formulation
- Aseptic purification processing
- Aqueous and non-aqueous solutions
Sterile Filtration:
- Capable of 0.2µ sterile filtration including highly viscous materials (100,000cP)
Filling:
- Gas overlay for oxygen-sensitive products
- Sterile, aseptic filling or non-sterile
- Filling of highly viscous solutions
- Vacuum filling and vacuum stoppering
- Heated or chilled filling
- Filling in low light conditions
Packaging:
- Label development
- Customized syringe components
- Trays, pouches
- Serialization
Testing:
- Extensive range of analytical services
- Development or transfer of new testing methods
- Secondary Sterilization
- Experience with ETO, gamma and steam sterilization