Sharp, a global leader in contract packaging and clinical supply services, part of UDG Healthcare plc, has confirmed a preferred partner agreement with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM).
As part of the agreement, Sharp will offer sterile fill/finish to augment its existing clinical manufacturing service to the pharmaceutical, biotech and clinical research sectors.
Massachusetts-based BSM is a fill/finish contract manufacturer incorporating 100% isolator-based sterile filling to its lines for syringes, vials and cartridges for the biotech and pharmaceutical industries. The isolator-based filling technology removes the risk of human contamination from the formulation and filling process.
Shawn Kinney, CEO of BSM said: “We are excited to be working with Sharp, a high-quality contract services organisation that can offer our clients downstream packaging, labelling, storage and distribution services in a fully seamless manner.”
Through the partnership, BSM will be able to offer its clients a comprehensive portfolio of complementary clinical trial supply and management services including analytical testing, stability, clinical and commercial packaging, serialization, IRT services, QP services, storage and distribution.
Frank Lis, President at Sharp Clinical, said: “This partnership with BSM is a natural extension to the clinical services we offer our clients and one that will see both parties benefit greatly from each other’s experience and expertise.
Sharp currently has dedicated clinical services facilities in Bethlehem, Pennsylvania and in Wales, UK both offering a broad spectrum of clinical services including cold storage, analytical, formulation development and commercial packaging.
Mr Lis continued: “Our clients will benefit enormously from the depth of expertise available to them through the team at BSM. We are very excited to be collaborating closely with such an industry leader in manufacturing and fill/finish and for the future of this relationship.”
The Sharp BSM partnership agreement comes into effect immediately.
Sharp, part of UDG healthcare, is a global leader in contract packaging and clinical services. Operating from eight state-of-the-art facilities across the US and Europe, Sharp has built an international reputation for delivering cost-effective blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, formulation and manufacturing services, label design and printing. Sharp is also a world leader in ’Track and Trace’ and serialisation services, with over nine years’ experience in implementing serialized solutions for its pharma clients.
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ABOUT BERKSHIRE STERILE MANUFACTURING
Berkshire Sterile Manufacturing Inc., is a leader in high quality clinical and small volume commercial manufacture of sterile injectable drug/biologic products and medical devices. BSM utilizes state of art isolator technologies to provide the greatest sterility assurance possible. BSM’s Lee, Massachusetts facility is FDA inspected and offers a variety of services including: sterile fill finish, analytical and microbiological testing, stability services and regulatory support.
For more information on BSM and its service offerings, visit www.Berkshiresterile.com.
Berkshire Sterile Manufacturing Contact