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ProBio

End-to-end CDMO services for biologics and cell & gene therapy from discovery to commercialization

ProBio is a leading global CDMO subsidiary of GenScript Biotech Corporation, providing end-to-end services for biologics and cell & gene therapy (CGT) from drug discovery through commercialization. Headquartered in United States.

Phases

Indications / Therapeutic Areas

Services

Modalities

Technical specifications & accreditations

Accreditations

About this organization

ProBio is a leading global CDMO subsidiary of GenScript Biotech Corporation, providing end-to-end services for biologics and cell & gene therapy (CGT) from drug discovery through commercialization. The company specializes in:

Core Capabilities:

  • CGT Solutions: Comprehensive CMC services for plasmid, viral vector, mRNA vaccine, and nucleic acid drugs, including cell banking, process development, characterization, validation, analytical method development, and stability studies
  • Biologics Discovery & Development: Therapeutic antibody discovery, antibody engineering, and in vitro/in vivo pharmacology studies
  • GMP Manufacturing: DNA-to-GMP material platform with stable cell line development, process development, analytical development, and clinical/commercial manufacturing using fed-batch and perfusion processes
  • Bioanalytical Services: Advanced analytical capabilities including Biacore surface plasmon resonance (8k and T200), high-throughput screening (HTS iQue Screener), and flow cytometry (BD FACS Calibur with HTS loader)

Regulatory Compliance: GMP capacity meeting FDA, EMA, and NMPA requirements. The company has supported customers in obtaining more than 130 IND approvals since October 2017.

Geographic Presence: Established operations in the United States, Netherlands, South Korea, and China (Hong Kong, Shanghai, Nanjing) serving global customers across North America, Europe, and Asia Pacific.

ProBio's mission is "Innovation through Collaboration," focused on shortening development timelines, reducing R&D costs, and accelerating biologics and CGT programs from discovery to commercialization.

Certifications

AuthorityIdentifierSource
FDAUS Food and Drug AdministrationView
EMAEuropean Medicines AgencyView
NMPANational Medical Products AdministrationView

Locations

  • United States

  • Netherlands

  • South Korea

  • Hong Kong

    Hong Kong · China

  • Shanghai

    Shanghai · China

  • Nanjing

    Nanjing · China

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