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    AtlanticPharma LLC

    CDMO
    Austria
    https://atlanticpharmallc.com

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    Manufacturing & Lab Equipment
    Contract Research Organization
    Qualification/Validation Services
    Analytical & Bioanalytical Services
    Excipients & Specialty Ingredients
    Company Overview

    About

    AtlanticPharma LLC is a leading contract development and manufacturing organization headquartered in Austria. We specialize in Small Molecule API Manufacturer, Analytical Testing with state-of-the-art facilities serving clients globally.

    Key Expertise

    Stability Studies, Small Molecule API, Sterile Injectable, Analytical Services, Formulation Development

    Therapeutic Areas

    Respiratory
    Allergy
    Quick Facts
    HQ:Austria
    Founded:1986
    Employees:10
    Capabilities & Services

    Core Capabilities

    • Biologics Drug Substance
    • Biologics Manufacturing
    • Formulation Development

    Types of Organization

    Advanced Therapy Manufacturer (cell, gene, mRNA, ADC)
    Analytical & Bioanalytical Laboratory
    Clinical Trial Supply & Logistics Provider

    Dosage Forms

    Sterile Injectable

    Containment Capabilities

    Cytotoxic / ADC Handling

    Production Scales

    Phase III Clinical Trials
    Commercial Scale
    Clinical

    Batch Sizes

    1L-10L
    10L-100L
    100L-1000L
    5000L+

    Markets Served

    North America
    Manufacturing Facilities

    2 sites worldwide

    AtlanticPharma LLC - Headquarters

    856 Technology Park, Graz, Graz, 20469
    View on Map
    138,140 sq ft
    Established 1995

    Site Capabilities

    5 capabilities
    Fill/Finish (Vials)
    Formulation Development
    Sterile Injectable
    Antibody-Drug Conjugates (ADC)
    Analytical Services

    AtlanticPharma LLC - North Carolina Facility

    723 Science Drive, North Carolina, North Carolina, 82770
    View on Map
    236,242 sq ft
    Established 2000

    Site Capabilities

    6 capabilities
    Viral Vectors
    Aseptic Processing
    Biologics Drug Product
    mRNA Production
    Antibody-Drug Conjugates (ADC)
    Fill/Finish (Vials)
    Regulatory Approvals
    Drug Approval S7WHLP
    FDA · #APR-8I807IXF · 2022-04-01
    Product Portfolio

    Premium Fill-Finish Service

    Brochure

    Our specialized service offering for CNS (Central Nervous System) and Cardiovascular applications.

    Lyophilized Powder
    Solution
    Injectable
    Ointment
    Delivery: Transdermal, IV Infusion, Subcutaneous

    Precision Formulation Service

    Brochure

    Our comprehensive service offering for Cardiovascular and Ophthalmology applications.

    Cream
    Ointment
    Delivery: Topical, Inhalation

    Case Studies

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

    Ophthalmology Monoclonal Antibody Development Partnership

    Pre-clinical
    Cell Therapy
    Small Molecule
    Sep 2019 – Jul 2022
    440 views

    Successful Pre-clinical manufacturing program for a leading biotech client.

    Challenge

    The client required rapid scale-up of their Ophthalmology therapeutic with aggressive timelines and complex analytical requirements.

    Solution

    We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.

    Outcome

    The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.

    Ophthalmology
    Download PDF

    Oncology mRNA Vaccine Development Partnership

    Pre-clinical
    Gene Therapy
    mRNA
    May 2022 – May 2024
    433 views

    Successful Pre-clinical manufacturing program for a leading biotech client.

    Challenge

    The client required rapid scale-up of their Oncology therapeutic with aggressive timelines and complex analytical requirements.

    Solution

    We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.

    Outcome

    The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.

    Oncology
    Immunology
    Download PDF

    CNS (Central Nervous System) Monoclonal Antibody Development Partnership

    Phase III
    mRNA
    Oct 2021 – Feb 2023
    234 views

    Successful Phase III manufacturing program for a virtual pharma client.

    Challenge

    The client required rapid scale-up of their CNS (Central Nervous System) therapeutic with aggressive timelines and complex analytical requirements.

    Solution

    We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.

    Outcome

    The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.

    CNS (Central Nervous System)
    Respiratory
    Download PDF
    Certifications

    FDA Registration

    U.S. Food and Drug Administration
    Cert #: CERT-R6WYEGAF
    Issued: 2020-06-07
    Expires: 2025-05-03

    EMA GMP Certificate

    European Medicines Agency
    Cert #: CERT-SS2YVMVF
    Issued: 2020-01-22
    Expires: 2025-10-02

    Health Canada GMP

    Health Canada
    Cert #: CERT-XRKWAIDB
    Issued: 2020-01-25
    Expires: 2025-04-20
    Customer Reviews
    4.4

    Overall Rating(Based on 13 reviews)

    Project Management4.8
    Technology Transfer4.7
    On-Time Delivery4.7
    Communication Responsiveness5.0
    Innovation3.0
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    Key facts about AtlanticPharma LLC

    • AtlanticPharma LLC is headquartered in Austria.
    • AtlanticPharma LLC was founded in 1986.
    • AtlanticPharma LLC has 10 employees.
    • AtlanticPharma LLC has 2 manufacturing sites listed on CDMO Hub, in Graz, Austria and North Carolina, United States.
    • AtlanticPharma LLC's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

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    Biologics Drug Substance CDMOsFormulation Development CDMOsSterile Injectable CDMOsCytotoxic / ADC Handling CDMOs
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