Analytical Development

Choosing the right partner for the development of your analytical methods is critical. SynCo’s scientists have a wealth of experience in a number of techniques and can advise on the best route for developing an analytical method specific for your product. 

SynCo can become involved in your analytical program at any stage. We can develop new analytical methods for the testing of raw materials, process intermediates, bulk drug substance samples, drug product samples and stability samples from scratch or improve and expand existing methods, and even troubleshoot and fix problematic analytical methods. Our method validation will be appropriate for your product development stage and comply with ICH guidelines. 

Analytical method development offered by SynCo covers a broad range of analytical methods, including SDS-PAGE and blotting techniques, ELISA based assays and various chromatographic methods. In addition, the analytical development department has state-of-the-art equipment that enables largely automated column scouting, as well as rapid fine-tuning of HPLC methods. 

Also the generic analytical methods (non-product specific) including safety assays can be established by SynCo suitable for the testing of in-process control and bulk drug substance or drug product samples.