Sharp, a global leader in contract packaging and clinical supply services, 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.
The investment at Heerenveen comes in response to the increasing demand from sponsors and manufacturers of gene therapies for dedicated, specialist packaging capacity. The Heerenveen site complements similar capabilities available at the company’s Bethlehem, PA facility, as it looks to offer support for clients in both the US and European markets.
The new secondary packaging area was designed to offer the optimal environment to address the complexities of gene therapies specifically, 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.
Services and support offered at Heerenveen includes:
- Storage, including freezer banks for multi-temperature ranges from -20 to -80
- Primary and secondary labelling of vials, pre-filled syringes
- Walk-in 2-8oC packaging suite
- Custom label generation for randomised clinical trials
- Secondary packaging & kitting
- Electronic batch records
- Serialization and aggregation
- QP services, including market release
On these new capabilities, 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. Everyone at Sharp is excited to collaborate with our clients as we help them bring life-changing and potentially curative therapies to the patients who need them.”
Heerenveen received Investigational Medicinal Product (IMP) and Wholesale Distribution Authorisation (WDA) licensing approvals in 2018, co-locating commercial packaging and clinical services at the facility.
Sharp is a global leader in clinical supply chain services and pharmaceutical packaging. For more than 65 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management. With facilities in the United States, United Kingdom, Belgium and the Netherlands and 30+ clinical depots globally, covering every region of the world, we are engineered to deliver.
Through our partnership with Berkshire Sterile Manufacturing, we offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization.
Our full complement of integrated services includes: research and development, clinical manufacturing, primary and secondary packaging of both investigational and commercial product, package design, serialization and aggregation, storage and distribution and clinical IRT. Sharp also offers Qualified Person (QP) services to meet the complex regulatory demands of the EU and UK.