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    Pepscan (Biosynth)

    CDMO
    Netherlands
    https://www.biosynth.com/biologics/epitope-mapping

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    Drug Product
    Analytical & Bioanalytical Services
    Company Overview

    About

    Pepscan (Biosynth) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:Netherlands
    Founded:1998
    Employees:2,105
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Sterile Injectable

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Phase II
    Clinical
    Pilot Scale

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval W26CHM
    Health Canada · #APR-2E49BC9N · 2021-01-01
    Drug Approval 22RJFU
    FDA · #APR-1NMJRKA6 · 2021-09-01
    Certifications

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-E1H6SZGJ
    Issued: 2020-06-03
    Expires: 2025-06-03

    Health Canada GMP

    Health Canada
    Cert #: CERT-AT5S7DUK
    Issued: 2020-12-13
    Expires: 2025-11-15
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    Key facts about Pepscan (Biosynth)

    • Pepscan (Biosynth) is headquartered in the Netherlands.
    • Pepscan (Biosynth) was founded in 1998.
    • Pepscan (Biosynth) has 2,105 employees.
    • Pepscan (Biosynth)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in NetherlandsCDMOs in EuropeBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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