Case Study – Transform
Drug Formulation Scale-Up
A pharmaceutical company had developed a new, non-soybean oil based formulation for an intravenous anesthetic agent. The bench scale process (<1L) was to be transferred to an outside contract manufacturing organization (CMO) to produce the formulation in 100L batches under cGMP guidelines for use in clinical trials. The process also had a number of complicating phenomena occurring during downstream filtration and the company lacked the necessary in-house resources to reliably scale-up the process.
IMPACT engineers reviewed all available process data including the formulation recipe, current laboratory methods, and the GMP manufacturing and aseptic processing goals. IMPACT then planned and executed an experimental test matrix to study mixing conditions, materials of construction, filtration issues, and product particle size requirements and the effect on product potency.
With the results of the experimental program, IMPACT defined a clear pathway for immediate scale up to 100L for clinical trials based on the client’s desired use of filtration. In addition, IMPACT gave consideration to long term commercialization of the process and made recommendations including conceptual designs of alternative process approaches. IMPACT recommended continued development activities to further study critical process variables.
“IMPACT helped us quickly evaluate the scalability of our process for one of our new drug product candidates. They were able to quickly supply us with the experience and technical horsepower that we needed to help us assess our process and meet our milestones.”
– Hongming Chen, S.M., SC.D.
Director, Formulation Design, TransForm Pharmaceuticals, Inc.