Sharp Services


Sharp is a global leader in pharmaceutical packaging, clinical trial supply services, and small-scale sterile manufacturing, with a heritage spanning over 70 years. They partner with pharmaceutical and biotechnology clients, offering solutions from phase I trials to commercial launch and lifecycle management. Their team leverages state-of-the-art GMP facilities across the US, UK, Belgium, and the Netherlands, committed to quality, innovation, and customer success.

Industries

Health Care
Biopharma
Biotechnology
Life Science
Pharmaceutical Manufacturing

Nr. of Employees

Very Large (1000+)

Sharp Services


Products

EU and UK Qualified Person (QP) Release Services

Qualified Person release services for the EU and UK markets.

Sterile Syringe Filling

State-of-the-art isolator technology based aseptic syringe filling services capable of handling challenging products such as viscous materials and suspensions, offering both manual and semi-automated processing.

Macungie Packaging Facility

A 315,000 sq ft pharmaceutical packaging GMP facility specializing in primary and secondary packaging services including bottling, vial labeling, pre-filled syringe, autoinjector and pen assembly, cartoning, and multi-component kitting.

Assembly, labeling and secondary packaging

Comprehensive contract packaging and assembly services for pharmaceutical and biotechnology products including pre-filled syringes, auto-injectors, and vials.

Clinical Services and Commercial Packaging Facility Rhymney

State-of-the-art clinical services and commercial solid oral dose packaging facility offering multi-phase pharmaceutical manufacturing, packaging, and distribution services.

Sterile fill-finish – syringes, vials, cartridges

Isolator-based sterile fill-finish services for syringes, vials, and cartridges.

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Services

Aseptic fill–finish for clinical and small-to-medium commercial sterile injectables, including isolator-based filling, lyophilization and terminal sterilization, delivered from GMP sites.

End-to-end clinical services including investigational product sourcing, analytical release testing, packaging, storage, depot network management, distribution and direct-to-patient solutions.

Primary and secondary pharmaceutical packaging services including high-speed bottle and blister lines, serialization and cold-chain packaging delivered from GMP facilities.

Implementation and managed delivery of interactive response technology and clinical inventory management systems to support patient randomization, supply allocation and trial supply visibility.

Selection, implementation and integration of Manufacturing Execution Systems and electronic batch record infrastructure to support production control, batch documentation and release workflows.

Partnership-based logistics and distribution capabilities to support international clinical trials, including regional depot operations, import/export handling and local market support.

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Expertise Areas

  • Clinical trial supply chain management
  • Sterile fill–finish manufacturing for injectables
  • Pharmaceutical primary and secondary packaging
  • Injectable device assembly and labeling
  • Show More (10)

Key Technologies

  • GMP sterile fill–finish processes
  • Isolator-based sterile filling
  • Lyophilization (freeze-drying) technology
  • Primary and secondary packaging machinery
  • Show More (6)

News & Updates

Sharp's new facility in Rhymney, developed since 2017 and approved by the UK’s MHRA in early 2019, is fully operational and offers an extended range of clinical services.

An article discussing the collaboration between Sharp and ClinsChain to support clinical trials in China, addressing challenges and solutions.

An article exploring the science behind filling viscous drug products, focusing on pumps, pressure, and process optimization.

An article explaining the importance of the UN Global Compact and Sharp's involvement.

An article discussing the challenges and solutions in designing secondary packaging for sterile injectables.

An article providing key questions to consider when preparing an IND application.

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