We perform pilot scale manufacturing as a verification of robustness of process.
Before transitioning from the laboratory formulation process to manufacturing, one must ensure that the process is robust, risk-free and reproducible. This is particularly true for expensive and material sensitive biological products.
Using the pilot-scale equipment in our laboratory, we ensure that the formulation and process is capable of maintaining the integrity of the product against unforeseen conditions such as agitations, manufacturing shears, numerous contact surfaces, and the environment.
- Vials, Ampules, and Pre-filled Syringe (PFS) Manufacturing
- Toxicology Supplies
- Reference Standards in Ampules (Most Stable Form!)
- Laboratory cGMP Stability Manufacture
- Potent Compounds and Oncology