A CRO/CMO pharmaceutical start up requested from Synergy to help with the set up and initial operation of their chemistry laboratory to support in the development and manufacturing of generic drug products. We started our collaboration effort by commissioning and qualifying the needed analytical instruments (HPLC, GC, TOC, etc.) and their related LIM System Software (Agilent OpenLab Software) as well as providing training and mentoring to the technical staff. Then, we worked on establishing the development strategy for the first three generic drug products the company wanted to start with. After that, we worked on developing the formulation study for the first drug product. During the formulation development, a dissolution variation problem caused by a complex relationship between process variables and raw material properties presented itself. Using the concept of Design of Experiment (DOE), we were able to identify key interactions between raw materials and process variables. This effort helped us identify the need to tighten raw material specifications to establish a bio equivalency between the generic formulation and the brand name drug product formulation.
In parallel with these activities, our scientists worked with the client’s technical team on developing and validating analytical methods for the drug products, establishing their Stability Indicating Studies, performing dissolution studies, as well as identified and quantified degradation components and profiling any residual solvents of the drug substances. Then, we developed and validated an analytical method for identifying and quantifying class III residual solvents and calculated the DPE limits for each solvent. The work for the first drug product was completed successfully and on time and was approved by the FDA. The client still has an ongoing relationship with Synergy, and we are still involved in drug development activities for them.
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