Parenteral Drug Formulation Development Process
Scaling your drug product from concept to commercial supply requires having the expertise to ask the right questions about your end goals, from the start.
Decades producing highly viscous sodium hyaluronate formulations (in excess of 100,000 cP) means we’ve developed expertise in unique products that are challenging to formulate, sterile filter, and aseptically fill.
We work closely with partners throughout their complete parenteral drug development program, ensuring that the final process is scalable and successfully transfers to a cGMP–compliant commercial manufacturing process.
Quality by Design (QbD) Based on ICH Q8 Guidelines
- Based on formulation needs and critical quality attributes (CQA), we determine Critical Process Parameters (CPP) and design GMP-compliant processes to meet those objectives.
- CQAs are evaluated, established, and monitored via in-process and final product tests to ensure specifications and release criteria are met.
- A dedicated project team maintains continuity from development to clinical and commercial manufacturing.
Product Types & Raw Material Components
- Hydrogels
- Microparticles
- Small molecules
- mAb fragments
- Proteins
- Modified Sodium Hyaluronate
- Polymers
- Emulsions
- Synthetic peptides
Depending on project requirements, equipment constructed from different materials such as glass, stainless steel, and single-use can be utilized.