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Small Molecule API and Intermediates CDMO Services

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Small Molecule API and Intermediates CDMO Services

Non-cGMP/cGMP Kilo Lab, Pilot and Commercial Production

Porton has two major manufacturing facilities in China: Changshou [Chongqing Metro Region] and Dongbang [Jiangxi Province]. Using a formal technology transfer system, site teams at these facilities have a highly successful track record of collaborating with the our three Process R&D centers to seamlessly provide integrated small molecule solutions, ranging from GLP tox lots, Phase I-IIII clinical supplies to full-scale commercial production in gram to MT quantities.

For rapid-turnaround / time-sensitive projects (typically GLP and/or early-phase clinical materials), we deploy special-purpose, multi-functional and flexible workshops, backed by a unique program management system to ensure that such materials are efficiently taken off critical path.

With over 700 m3 of flexible capacity [including specialized capabilities such as high-pressure hydrogenation up to 50 bar, large-scale potent molecule production and bio-catalytic process scale-up], Porton’s Changshou Facility has successfully received USFDA, EMA, PMDA and NMPA inspections. The site also offers a comprehensive range of reaction technologies including high temperature (up to 250oC), cryogenics (-80oC) etc.

Porton’s Dongbang Facility offers ~500 m3 of specialized capacity [including scale-up of some hazardous processes], and serves as our key back-integration site, offering highly cost-effective and reliable supply of starting materials and early intermediates in full compliance with appropriate Quality and EHS requirements.

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