Sharp completes new gene therapy packaging and distribution capacity in 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 2-8oC packaging suite, as well as freezer banks with a range of temperatures to -80oC. 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”.