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    MassBiologics (UMass Chan)

    CDMO
    United States
    https://www.umassmed.edu/massbiologics/

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    Drug Product
    Advanced Modalities
    Analytical & Bioanalytical Services
    Company Overview

    About

    MassBiologics (UMass Chan) is a pharmaceutical CDMO offering comprehensive services.

    Key Expertise

    Specialized in Gene Therapy, Cell Therapy, mRNA

    Therapeutic Areas

    Cardiovascular
    Endocrinology
    Quick Facts
    HQ:United States
    Founded:2000
    Employees:2,369
    Capabilities & Services

    Core Capabilities

    • Sterile Injectable
    • Sterile Fill/Finish
    • Fill/Finish (Vials)

    Types of Organization

    GMP Manufacturing
    Quality Systems
    Regulatory Support

    Dosage Forms

    Cartridge / Pen

    Containment Capabilities

    BSL-2 (Biosafety Level 2)

    Production Scales

    Commercial Scale
    Large Scale (Metric Ton+)

    Markets Served

    Europe
    Regulatory Approvals
    Drug Approval 5CX620
    EMA · #APR-DQ919QGD · 2021-10-01

    Case Studies

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

    Certifications

    ISO 9001:2015

    International Organization for Standardization
    Cert #: CERT-6SB4CO64
    Issued: 2020-08-19
    Expires: 2025-03-24

    ISO 13485:2016

    International Organization for Standardization
    Cert #: CERT-J0R750B3
    Issued: 2020-11-28
    Expires: 2025-12-06

    MHRA GMP

    UK Medicines and Healthcare products Regulatory Agency
    Cert #: CERT-947DQARA
    Issued: 2020-12-07
    Expires: 2025-11-21
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    Key facts about MassBiologics (UMass Chan)

    • MassBiologics (UMass Chan) is headquartered in the United States.
    • MassBiologics (UMass Chan) was founded in 2000.
    • MassBiologics (UMass Chan) has 2,369 employees.
    • MassBiologics (UMass Chan)'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

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    CDMOs in United StatesCDMOs in North AmericaSterile Injectable CDMOsFill-Finish CDMOsFill/Finish (Vials) CDMOsCartridge / Pen CDMOsBSL-2 (Biosafety Level 2) CDMOs
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