How do you make a completely single-use biologics manufacturing process?

GenScript ProBio has two biologics manufacturing facilities, located in Nanjing, China, with 2,600L scale GMP manufacturing capacity. Built to comply with international GMPs and provide one-stop CDMO service from cell line development, process development, and GMP clinical manufacturing, Bio-R&D center was launched in 2019 for biologics manufacturing of preclinical CMC and clinical phase I, with total area of 8,640m2 and 2x 200L production capacity. Bio-GMP center was launched in 2020 for biologics manufacturing of clinical phase I&II, with total area of 10,700m2 and 6 x 200L & 2 x500L capacity.

GenScript ProBio owns three segregated large-scale cell culture upstream production lines in Bio-GMP center, with a total culture volume of 2,200L and two segregated downstream purification production lines.

Bio-GMP center has strict physical isolation rules so that multiple samples can be produced simultaneously. The whole process, including solution preparation, cell culture, downstream chromatography and filtration, adopts single-use technology that effectively avoids the risk of cross-contamination. The fully single-use system includes Cytiva XDR 200L/500L and Thermo Fisher HyPerforma 200L/500L bioreactors, 10mm ÄKTA Ready chromatography unit, Merck Mobius single-use filtration skids and corresponding disposable consumables.

Bio-GMP center has zero-crossover production lines, unidirectional flow design, fully closed system & process and independent heating, ventilation and air conditioning (HVAC) system. The clean utility meets global standards, such as ASME BPE, Chinese Pharmacopeia (CP), U.S. Pharmacopeia (USP) and European Pharmacopeia (EP) requirements. Automation system, environment management system and building management system are also equipped with high global standard.

In addition, GenScript ProBio Technology Transfer Team has established a comprehensive and refined technology transfer process and has implemented comprehensive risk control in the technology transfer process, which ensures the smooth transfer of customer projects and the successful completion of landing production.