Sharp completes new gene therapy packaging and distribution capacity in The Netherlands

By Rachel Arthur contact

- Last updated on GMT

Sharp completes new gene therapy packaging and distribution capacity in The Netherlands

Related tags: The Netherlands, gene therapies, Gene therapy

Contract packaging and clinical supply services company Sharp has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of gene therapies at its facility in Heerenveen, The Netherlands.

Sharp eyes up increasing demand from sponsors and manufacturers of gene therapies for dedicated, specialist packaging capacity: investing in Heerenveen in response.

The site offers both large scale and small-batch packaging in multiple specialist formats: and complements similar capabilities available at the company’s Bethlehem, PA facility: thus offering these services in both the US and Europe.

Cold and ultra-cold supply chains

The Heerenveen site underwent a complete renovation in 2018 to allow Sharp to co-locate commercial packaging and clinical services at the same location: receiving Investigational Medicinal Product (IMP) and Wholesale Distribution Authorisation (WDA) licensing approvals that year.

Now, a new secondary packaging area has been added to offer the optimal environment to focus on the complexities of gene therapies: labelling and packaging vials and injectables at low volumes and low temperatures, for distribution in cold and ultra-cold supply chains.

The Heerenveen facility includes air handling systems, controlled temperatures and humidity, a walk-in 2-8o​C packaging suite, as well as freezer banks with a range of temperatures to -80o​C.  The site also provides key operational efficiencies through its electronic batch record and a standardized quality management system. 

Vesna Bondzulic, site manager at Sharp Heerenveen said: “We recognise the enormous promise of gene therapies, as well as the unique complexities they can present to traditional pharma supply chains.

“Sharp can offer a blend of commercial packaging and small-scale clinical supply expertise to address these challenges for our clients, as well as QP market release for the European market”.

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