A global biopharma company partnered with Syngene for Bioanalytical studies for PK, ADA and NAb assays. In less than a year of the collaboration, the company decided to make Syngene, its preferred CRO lab for a novel molecule for migraine. The molecule went on to receive FDA approval in 2018.
Bolstered by the success of this project, the company recommended Syngene to its co-development partner, a global, pharma company. The result was a 3-way partnership between the biopharma company, their co-development partner and Syngene for supporting clinical trials with Pharmacokinetics, Immunogenicity and Neutralizing antibody data using the biopharma company’s proprietary methods.
Today, besides expanding its collaboration with the biopharma company, Syngene is working with their co-development partner on 3 novel molecules and 9 clinical studies.
Needless to say, the programs discussed in this case study are excellent examples of how a Pharma-CRO partnership can extend beyond company borders into wholistic drug development activities for global licensing.