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Help 9 clients get IND approved from FDA, NMPA, PMDA
High density and large-scale fermentation
Process and Analytical Development
GMP AAV Vector Production
Targeting multiple biological drug modalities
Gram-to-kilogram level large-scale material supply
BPG quality system enabling IVD raw material production
• >2g/L titer
• 12 weeks from DNA to purified material
• High batch to batch consistency
GenScript ProBio developed the distinguishing Phase-appropriate Compliance (PAC) quality system to meet worldwide stringent regulatory standards (including US-FDA/EU-EMA/China-NMPA), which will benefit our customers in a way of high quality, cost-effectiveness, efficiency and credibility.
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Our team and leaders have years of experience in global biopharma companies. Our PMs are trained scientists with PhD degree in the US and Europe.
Probio RA team is committed to provide professional regulatory support on CMC development of biological products. We have confidence to provide strong support for your projects.
Current capacity: up to 20 GCT IND and 400 L biologics. Total 16,800 L bioreactors by 2023.
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Awards
GenScript ProBio is the bio-pharmaceutical CDMO segment of GenScript, proactively providing end-to-end service from drug discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers.
GenScript ProBio is the leading biologics CDMO which offer innovative solutions for antibody drug development include antibody drug discovery, antibody engineering and antibody characterization. In terms of biologics development service, GenScript ProBio has built a regulatory-compliant platform, from stable cell line development to clinical manufacturing services, providing high quality material for IND and clinical trials. GenScript ProBio's total gene and cell therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.
Toward the mission of "Innovation through Collaboration", GenScript ProBio is committed to helping customers significantly lower R&D costs and building a healthier future.