PharmaBlock Sciences has acquired a GMP compliant manufacturing facility in China from Porton Pharma Solutions. Earlier this month, the company announced the appointment of new CTO, Dr. Shijie Zhang from Agios Pharmaceuticals.
The 1,436,000ft2 site, located in a State-level chemical industry park in Shangyu, Zhejiang Province, has been operating as a multi-purpose GMP compliant facility since December 2015. Assets include reactors from 300L to 6300L, with more than 180m3 of combined reactor volume. The facility is well equipped to practice a wide range of chemistry synthesis and enabling technologies. It has delivered 100+ non-GMP and GMP intermediates from Phase I to commercial, with production over 150 MT since January 2016.
“PharmaBlock’s new Shangyu site is well positioned to respond to customers’ increasing demand for preclinical-, clinical- and commercial- stage manufacturing of intermediates. The acquisition of this site provides additional GMP capacity and is supplement to our existing assets in Shandong Dezhou site.” said Dr. Minmin Yang, Chairman of PharmaBlock. “We will initiate the Phase II construction of Shangyu facility within this year to establish API manufacturing capabilities. In this way, PharmaBlock will soon be able to offer customers an integrated supply chain from building blocks, non-GMP intermediates, GMP intermediates to APIs.”
PharmaBlock has a base of novel building blocks design and synthesis for small molecule drugs R&D. In 2016, PharmaBlock acquired Shangdong Diai Biotechnology as its first pilot plant and manufacturing site. It is reported in the company’s semi-annual report, that the half year revenue in 2018 surged 72.83% to $31.94 million. The growth is largely contributed by the increasing development and manufacturing projects.
Early this month, the company appointed its new Chief Technology Officer- Dr. Shijie Zhang. Shijie joins the company from Agios Pharmaceuticals, Inc., where he led the CMC API team for the two FDA-approved therapies (Idhifa, Tibsovo), by managing and overseeing API development programs and manufacturing activities spanning from preclinical stage to commercial stage, and preparing API sections of regulatory filing documents, including IND, IMPD, NDA, and briefing documents etc..
“Bringing Dr. Shijie Zhang to the team will get a step further to improve the QA system, and extend competence in process development and manufacturing to support clients’ late phase and commercial programs, thus to strengthen the company’s competitiveness in CDMO business.” Said Dr. Haijun, Dong, Chief Executive Officer of PharmaBlock.