SPEAKER: DR. XIAO PAN
TIME: 2022.07.14 15:00-16:00 KST
One-stop solutions of Bioactivity
Characterization for Drug Approval
One-stop solution for bsAb discovery
Compatible with almost any mAb and bsAb sequence
Excellent cell line performance, >4E14 vg/L crude titer
GMP LVV Mfg
Pro LVV Mfg
LVV CMC study
Targeting multiple biological drug modalities
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 is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.
GenScript ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In plasmid service, it has established the largest commercial GMP plasmid manufacturing facility and also is the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines. As the first lentiviral vector CDMO and the leading adeno-associated viral (AAV) supplier in China, it has established two core technology platforms: lentiviral vector and AAV vector. Both LVV and AAV suspension platform own self-developed lentiviral vector suspension cell line.
GenScript ProBio’s innovative solutions for biologics discovery and development include therapeutic antibody discovery, antibody engineering and antibody characterization. In biologics development service, it has built a DNA to GMP material platform, including stable cell line development, host cell license, process development, analytical development to clinical manufacturing, and offer fed-batch and perfusion process to meet the growing needs for antibody and protein drugs.
Toward the mission of “Innovation through Collaboration”, GenScript ProBio is committed to helping customers significantly lower R&D costs and building a healthier future.