√ For mAb: 6 months from Sequence to Tox batch completion
√ For bsAb: 7 months from Sequence to Tox batch completion
Flexible solutions for IIT material, IND material and GMP material
As fast as 3.5 months from DNA to GMP material
√ 4-Week Turnaround Time
√ Full QC Release
√ Half Turnaround Time: 4 Weeks
√ Shorter Time with High Quality
One-stop solutions of Bioactivity
Characterization for Drug Approval
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 CGT IND and 400 L biologics. Total 16,800 L bioreactors by 2023.
GenScript ProBio, a subsidiary of GenScript Biotech Corporation, offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in CGT, vaccine and antibody protein drug, aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 50 IND approvals since October 2017.
GenScript ProBio’s total CGT solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. GenScript ProBio’s innovative solutions for biologics discovery and development include therapeutic antibody discovery, antibody engineering and antibody characterization. In the biologics CDMO service, GenScript ProBio has built a DNA to GMP material platform, including stable cell line development, host cell commercial license, process development, analytical development to clinical and commercial manufacturing, and offer fed-batch and perfusion processes to meet the growing needs for antibody and protein drugs. GenScript ProBio has established GMP capacity that meets regulatory requirements of the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and National Medical Products Administration (NMPA).
Toward the mission of “Innovation through Collaboration”, GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization, significantly lowering R&D costs and shaping a healthier future.