PharmaBlock acquires GMP-compliant manufacturing facility
PharmaBlock Sciences (Nanjing), a leading innovative chemistry product and service provider throughout the pharmaceutical R&D process, has acquired a GMP compliant manufacturing facility in China from Porton Pharma Solutions Ltd. Last month, the company announced the appointment of new CTO, Dr. Shijie Zhang from Agios Pharmaceuticals.
New site to add GMP manufacturing capacity
The 1,436,000ft2 (approximately 133,400m2) 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 well-established base of novel building blocks design and synthesis for small molecule drugs R&D. As many of its 41,000 building blocks have been applied in clinical stages, the demand quantities of the building blocks and advanced intermediates keep increasing from grams to kilograms to metric tons. In 2016, PharmaBlock acquired Shangdong Diai Biotechnology Ltd. as its first pilot plant and manufacturing site. Obviously, the rising demand is close to outstripping supply. It is reported in the company’s semi-annual report, that the half year revenue in 2018 surged 72.83% to 31.94 million USD. The growth is largely contributed by the increasing development and manufacturing projects.
New CTO to take the CDMO business a step further
In addition to the investment in manufacturing capacity, PharmaBlock has been continuously strengthening its capabilities in process R&D and improving quality system to better serve customers’ need.
Last 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.
Over the past two years, PharmaBlock has made great progress in expanding process chemistry and implementing an array of enabling technologies of flow chemistry, biocatalysis, photochemistry, electrosynthesis, and fluorination etc. The company’s process R&D center in China is sited in Nanjing, where the company has purchased another 330,000 ft2 land for a new Discovery and Process R&D Center. PharmaBlock also boosts its footprint in United States with the renovation of it new Process R&D Center in Philadelphia Suburbs. As Phase I of the PharmaBlock Pennsylvania site, the 7,000 sq ft facility is now in fully operation.