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News 2021-06-20

WS109, Porton’s New Multi-Purpose cGMP API Workshop Goes on Stream

June 18, 2021, Chongqing, China: Porton Pharma Solutions Ltd. (Stock code: 300363, hereinafter referred to as "Porton") announced the commissioning and full operation of a new multi-purpose cGMP-compliant small molecule API workshop (hereinafter referred to as "Workshop 109") at its world-class Changshou Manufacturing Facility in Chongqing, China. Deploying cutting-edge Intelligent Manufacturing concepts and advanced automation tools Workshop 109 exemplifies the new frontier in smart Pharmaceutical Manufacturing and will reliably deliver accelerated and high-quality production outcomes. Workshop 109 significantly expands Porton’s small molecule API manufacturing capacity to effectively meet our global customers’ rapidly increasing demand and robustly enable their clinical development and/or Go-To Market strategies.

Offering 187 m³ of flexible and high-quality production capacity, Workshop 109‘s reactor volumes range from 1,000L to 10,000L and can efficiently support clinical trial material and commercial-scale requirements. A state-of-the-art DCS system seamlessly integrates hardware to offer superior vessel operability, flexibility – while ensuring safety and reliability of process control to the highest standards.

  

Since its inception in 2006, Porton's Changshou Manufacturing Facility has remained a core small molecule production site anchoring our globally recognized API CDMO business. Through targeted expansions and with the trusted, long-term support of our many global customers, Porton Changshou now offers 12 high-quality production workshops with a total capacity of approximately 900 m³. Specialized technologies practiced on scale include cryogenics (-80℃), high temperature (250℃), high vacuum distillation, wiped film evaporation, column chromatography, cGMP hydrogenation, asymmetric hydrogenation, crystallization, biocatalysis, and flow chemistry . Backed by a proven quality management and EHS system, Porton Changshou has successfully received inspections from most major global regulatory bodies including the USFDA, EMA, PMDA, NMPA and WHO, in addition to passing >300 audits conducted by multi-national pharmaceutical companies and biotech companies from across the world.

Mr. Ju Nianfeng(Oliver Ju), Chairman and GEO of Porton, said at the event:
 “First of all, I would like to take this opportunity to thank all our partners for their presence at this event. The inauguration and full operation of Workshop 109 not only marks another substantial increase in production capacity for Porton's small molecule business, but also an important step for us to introduce high levels of automation and AI-based smart manufacturing digital tools in the CDMO environment. As the new era of Industrial Manufacturing 4.0 dawns, Porton will use such smart technologies to realize very significant increases in production efficiency, thus accelerating the push towards new frontiers in pharmaceutical manufacturing Promoting such a transformation, Porton joins hands with our customers and partners to broaden the horizons, and achieve our core mission of 'making good medicine to benefit the public faster.” 

Mr. Wang Fengping, General Manager of Changshou Site, said at the event, “The construction of Workshop 109 was launched in October 2019. The schedule operation was eventually achieved with our team’s unremitting efforts and partners’ strong support, despite the global Covid-19 pandemic’s impact on such aspects as supply chains and construction progress. Leveraging our Changshou Facility’s vast production experience since 2006, and yet representing a new-paradigm manufacturing asset, Workshop 109 will effectively address the pharmaceutical industry’s rapidly evolving requirements through automation, and smart digital tools designed for high flexibility, operational ease and safety. We’ve been keeping our feet on the ground and playing the long game to chart our own path towards ‘intelligent manufacturing’. Workshop 109 is our first step, in this direction. Through this and other future initiatives, Porton will continuously set new benchmarks for efficiency, thus empowering our customers to more rapidly deliver highly impactful health outcomes for their patients worldwide.” 

Ribbon Cutting Ceremony

Nameplate Unveiling Ceremony

We were honored to have representatives from the Chinese divisions of our global partners, which include Janssen, Sanofi, MSD, and Suzhou Sinovent to grace the occasion and witness this event.

Photo: Guests visiting Workshop 109

About Porton

Founded in July 2005, Porton Pharma Solutions Ltd. (Stock Code: 300363) is a leading China-based pharmaceutical CDMO (Contract Development Manufacture Organization). Serving all stages of clinical development and the drug life cycle, Porton provides global pharmaceutical companies with customized process R&D and world-class cGMP-compliant manufacture of small molecule APIs, finished dosage formulations, gene and cell therapeutics. With more than 2,800 customer-centric employees, we offer global reach through operations and branches in China (Chongqing, Chengdu, Shanghai, Yichun, Suzhou, and Hong Kong), United States, Belgium, Switzerland, and the United Kingdom.

 

 

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