May 21, 2020, Chongqing • China—Porton Pharma Solutions Ltd. (SZSE: 300363, hereafter referred to as Porton) today announced the opening of integrated cGMP Laboratories at its Chongqing Process Technology Center, China.  This marks a major milestone in Porton’s API offering to global pharmaceutical companies.

In addition to existing cGMP Analytical Laboratories at its Chongqing Process Technology Center, Porton’s cGMP Solutions Suite features a Kilo Laboratory, SFC Separations Laboratory and a warehouse for storing raw materials, intermediates and finished APIs all operating to cGMP standard – thus fully supporting cGMP production and release of early-phase clinical API supplies.

Porton’s Chongqing Process Technology Center and cGMP Solutions Suite and our nearby cGMP-compliant, USFDA/EM/PMDA-inspected Changshou Manufacturing Facility together seamlessly enable full life-cycle management of products for global pharmaceutical companies..

Porton’s J-STAR, unit located in New Jersey, US also offers cGMP solutions spanning process research, preparation of early-phase pre-clinical and Phase I API supplies including a fully cGMP-compliant highly potent molecule synthesis laboratory.  The combination of our US and China facilities thus enables best-in-class, full life-cycle API CDMO services with proven, industry-leading quality and customer service standards for global pharmaceutical companies.

“Since the Company’s inception, Quality management and building a unique quality-centric culture has always been Porton’s top priority.  Now with more than 10 years’ experience of reliably providing CDMO services for global pharmaceutical companies, Porton has demonstrated its capabilities to meet and exceed Quality expectations of our customers,” said Kerry Yu, SVP of Porton, in the opening ceremony today. “The launch of our cGMP Solutions Suite in Chongqing reinforces our ability to confidently undertake and deliver early-phase clinical cGMP projects, while further growing our world-class late-phase and commercial-scale manufacturing platform. Porton’s management and employees will unswervingly move forward with the set goals to deliver exceptional value for all our stakeholders while helping to improve global human health.”

“Today, with the launch of our GMP Solutions Suite n Chongqing, Porton’s Process Technology Center has established a comprehensive system to meet our clients’ early-phase API requirements.  This marks a major milestone and an important moment for the Company's strategic transformation. Porton is now capable of providing fully integrated and “co-located” cGMP services to enable clinical API supplies ranging from process development , analytical method development and safety testing, followed smoothly by cGMP scale-up and release all under one roof and at one location.  In doing so, Porton’s cGMP Solutions Suite will bring the key forces of innovation, speed and rigorous Quality to our customers’ early-phase APIs in the critical early phase clinical area,” said Yaohui Ji, R&D VP of Porton, today at the ceremony. “We will also bring the existing non-GMP highly potent molecule synthesis laboratory into cGMP compliance and embed this critical capability into our cGMP Solutions Suite in Chongqing.  Also having successfully completed a non-GMP SFC separation project, the cGMP Solutions Suite will allow us to execute such separations in a fully cGMP environment.”  

Porton operates 4 Process Technology Centers across China and the US.  Collectively, they feature more than 70 laboratories, over 500 process R&D scientists and other technical staff.  Collaborating effectively with our colleagues in Quality, EHS and Project Management, Porton’s scientists are building a world-class End-to-End CDMO Services platform that includes cutting-edge expertise in crystallization, catalysis, highly potent molecule assembly, flow chemistry and SFC.  We thrive on our foundational values of "Customer First" and "Technology and Service Innovation".