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    3. /Axcelead Drug Discovery Partners (DDP)
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    Axcelead Drug Discovery Partners (DDP)

    CDMO
    Japan
    https://axcelead-us.com/

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    Analytical & Bioanalytical Services
    Contract Research Organization
    Company Overview

    About

    Axcelead Drug Discovery Partners (DDP) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:Japan
    Founded:2003
    Employees:2,443
    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

    R&D / Pre-clinical
    Lab Scale
    Pilot Scale

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval TPWGUO
    PMDA · #APR-VMZMUC7T · 2022-10-01

    Case Studies

    0 published case studies showcasing past projects, challenges and outcomes.

    Certifications

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-F5K4SVZF
    Issued: 2020-01-28
    Expires: 2025-02-21

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-J7KPACQP
    Issued: 2020-07-05
    Expires: 2025-04-24

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-ON851SLR
    Issued: 2020-07-21
    Expires: 2025-10-07

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-0OA0ZDFH
    Issued: 2020-06-03
    Expires: 2025-03-01
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    Key facts about Axcelead Drug Discovery Partners (DDP)

    • Axcelead Drug Discovery Partners (DDP) is headquartered in Japan.
    • Axcelead Drug Discovery Partners (DDP) was founded in 2003.
    • Axcelead Drug Discovery Partners (DDP) has 2,443 employees.
    • Axcelead Drug Discovery Partners (DDP)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    CDMOs in JapanCDMOs in AsiaBiologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsBSL-2 (Biosafety Level 2) CDMOs
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