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Heerenveen, The Netherlands

Sharp’s Heerenveen facility provides both large-scale and specialised small-batch packaging capacity in shared or dedicated production suites. We offer expertise and capabilities in multiple specialist formats, and enables access to the EU market through in-house QP services.

Our facility also offers a complete range of specialized cold chain packaging and labelling services for gene therapy products. A specialist infrastructure is in place including temperature and humidity controls and monitoring, and full -80°C freezer banks in shared or dedicated packaging suites.

Sharp Heerenveen holds also a European clinical services depot offering distribution and QP release services for investigational medicinal products (IMPs) in conjunction with our site in Rhymney, UK.

Facility Highlights

    • 8,500 m2 (92,100 ft2) facility including GMP production space, warehouse and offices
    • Ambient and refrigerated (2-8°C) packaging, storage, and distribution
    • Frozen (-80°C) storage and distribution
    • Shared and dedicated production areas
    • Controlled drug management
    • Manufacturing License for Wholesale Distribution Authorisation (WDA) and Investigational Medicinal Product (IMP)
    • Electronic Batch Record (EBR) generated via our Manufacturing Execution Systems (MES)
    • Gene therapy small-batch cold chain packaging suite
        • Optimal environment and specialist infrastructure
        • Dedicated HVAC air handling
        • Temperature and humidity controls and monitoring
        • Full -80°C freezer banks in dedicated production suite

Contract Services

Secondary packaging

Quality Accreditation

    • Regulated by Dutch Health and Youth Care Inspectorate (IGJ)
    • Ministry of Health of the Republic of Belarus – inspected
    • Ministry of Industry and Trade of the Russian Federation – inspected
    • Manufacturing License 108630F WDA 16273G
    • GMP certified

Contact

Neptunus 12
8448 CN Heerenveen
The Netherlands
Tel: +31 513 433 947
info@sharpservices.com

Allentown, PA, US – Building 1

7451 Keebler Way, Building 1, Allentown, PA 18106 United States

+1-610-395-5800

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7384 Penn Drive, Building 4
Allentown, PA 18106
United States

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2400 Baglyos Circle,
Bethlehem, PA, 18020,
United States

+1-484-765-9900
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