Porton has successfully completed process validation (PV) of a major New Chemical Entity (NCE) drug for a US-based pharmaceutical innovator. Throughout this complex, 2-year project, Porton provided seamless end-to-end services across technology transfer, process/analytical development, analytical methods validation, preparation of PV documentation and cGMP-compliant production.  The conclusion of this program within the originally committed timeline highlights Porton’s sophisticated capabilities in API development and commercialization, while marking yet another milestone in Porton’s rapid transformation into a globally impactful API CDMO.

In the course of this project, Porton spearheaded process design and development, executed Quality by Design (QbD) studies including confirmation of Proven Acceptable Range (PAR) and Normal Operating Range (NOR) for various process parameters, conducted impurity purging / fate studies, and established  specifications for the Registered Starting Material (RSM) and downstream drug intermediates.

Mr. Yaohui, Ji, VP, R&D and Project Management at Porton said, "the successful, on-time conclusion of this PV project is clear evidence of Porton’s ability to reliably execute complex late-phase programs in support of our customers’ global filings and launches.  We continue to enhance our capabilities across the full spectrum of API CMC activities, while investing substantial resources and capital in our core process technologies of crystallization R&D, Bio-catalysis and Flow Chemistry."

Porton continues to help global pharmaceutical companies advance their drugs through late-phase clinical development and enable regulatory filings in anticipation of launch.  We are engaged in 5 additional NCE PV programs this year, further demonstrating our esteemed customers’ confidence in Porton’s industry – leading competencies and reinforcing our value proposition as an innovation-driven, quality-focused and reliable API CDMO.  

Learn more at www.porton.cn