3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in the process development and GMP manufacturing of biologics, has signed a collaboration agreement with the Dutch biotech company Xenikos that will cover the global manufacturing of Xenikos’ proprietary lead product candidate T-Guard.

 
3P and Xenikos started their collaboration in 2015 and now, according to this new agreement, 3P is responsible for the process transfer and scale-up, cGMP production for clinical trials and process validation.
 
T-Guard is a novel therapeutic approach designed to help reset the immune system in patients who have a severe immune disease or have developed post-transplantation rejection. T-Guard consists of a unique combination of two toxin-conjugated monoclonal antibodies that has been shown in preclinical and early clinical testing to safely and swiftly restore a patient’s immune system.
 
“We are very pleased to continue working with Xenikos on this project and to create a strong long-term partnership with them,” said Dámaso Molero, general manager, 3P Biopharmaceuticals. “This collaboration proves the experience and know-how of 3P’s services for recombinant protein production in both mammalian and microbial expression systems. 3P, as a global manufacturing partner, has proven expertise in commercial production as well as in process validation and process characterization.”
 
Ypke van Oosterhout, chief executive officer, Xenikos, said, “The successful process development and the smooth technology transfer of T-Guard’s GMP manufacturing turned out to be a real team effort. In this process, we have come to know 3P as an appreciated, flexible and reliable service partner that delivers on its promises. We look forward to continuing our collaboration and having the tremendous expertise of 3P on our side as we move our lead candidate into Phase 3 clinical development.”