PharmaBlock Acquires a GMP compliant Manufacturing Facility to Support Ongoing Customer Demand

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Sep 28, 2018, 08:00 ET

Facility is acquired from Porton Pharma Solutions Ltd., and operated with GMP compliance.
Located in a State-level chemical industry park, the facility expands PharmaBlock's manufacturing capacity of building blocks, RSMs, non-GMP and GMP intermediates.
Capacity includes over 180m³combined reactor volume, ranging from 300L to 6,300L of reactor size. It has delivered 100+ products from Phase I to commercial, with production over 150 MT since January 2016.
Phase II construction will be implemented this year to establish API manufacturing capabilities.

NANJING, China, Sept. 28, 2018 /PRNewswire/ -- PharmaBlock Sciences (Nanjing), Inc. (SZSE: 300725), a leading innovative chemistry product and service provider throughout the pharmaceutical R&D process, announced today that it has acquired a GMP compliant manufacturing facility in China from Porton Pharma Solutions Ltd. Earlier this month, the company announced the appointment of new CTO, Dr. Shijie Zhang from Agios Pharmaceuticals, Inc.

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. 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.

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.

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 ft²land 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.

About PharmaBlock

PharmaBlock Sciences (Nanjing), Inc. (SZSE: 300725) is a leading provider of innovative chemistry products and services throughout the pharmaceutical R&D process. Officially operated in 2008, PharmaBlock has rapidly gained recognition for its outstanding capability in the design, synthesis, and supply of novel building blocks for drug discovery use. With more drug R&D projects adopting the company's products advance from discovery to preclinical and clinical research, even into commercialization, PharmaBlock moved on to build up top notch process R&D capabilities, and is providing scale-up synthesis and manufacturing of key intermediates/RSMs. The company is now committed to a more comprehensive and long-term service to valued customers.

Over the past years, PharmaBlock has partnered with over 80% of the top 20 pharmaceutical companies, and hundreds of small to medium-sized biotechs around the world. In 2012, the company opened a facility in the San Francisco Bay Area, and set up the United States headquarters in Pennsylvania in 2017, expanding the inventory, customer service and lab functions for more efficient and timely services to local customers in the United States and Europe.

SOURCE PharmaBlock