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    LucasPye BIO

    CDMO
    United States
    https://lucaspye.com/

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    Drug Product
    Advanced Modalities
    Analytical & Bioanalytical Services
    Regulatory, Tech Transfer & Support Services
    Company Overview

    About

    LucasPye BIO is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

    Therapeutic Areas

    Immunology
    Rheumatology
    Quick Facts
    HQ:United States
    Founded:1993
    Employees:1,667
    Capabilities & Services

    Core Capabilities

    • Peptide Synthesis
    • Small Molecule API
    • Formulation Development

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Inhalation

    Containment Capabilities

    OEB 4 (1-10 µg/m³)

    Production Scales

    Pilot Scale
    Phase I Clinical Trials
    Clinical

    Markets Served

    Global
    Regulatory Approvals
    Drug Approval 59V6JV
    EMA · #APR-GNBMUME5 · 2018-04-01
    Certifications

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-7CJSA917
    Issued: 2020-07-16
    Expires: 2025-01-16

    WHO GMP

    World Health Organization
    Cert #: CERT-0ZYVWIFH
    Issued: 2020-06-14
    Expires: 2025-09-02

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-J9V6467B
    Issued: 2020-05-20
    Expires: 2025-01-27

    Health Canada GMP

    Health Canada
    Cert #: CERT-WVQ3GEOV
    Issued: 2020-04-06
    Expires: 2025-09-03
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    Key facts about LucasPye BIO

    • LucasPye BIO is headquartered in the United States.
    • LucasPye BIO was founded in 1993.
    • LucasPye BIO has 1,667 employees.
    • LucasPye BIO's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

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    CDMOs in United StatesCDMOs in North AmericaSmall Molecule API CDMOsFormulation Development CDMOsInhalation CDMOsOEB 4 (1-10 µg/m³) CDMOs
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