• Enabling Fast And Appropriate Drug Product Supply For Phase 1 Clinical Trials

    Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs. Since many of them are completely virtual or have limited lab space capabilities, they often do not have in-house resources and capacity for formulation development. Without the ability to move smoothly from lab concept to the manufacture and delivery of GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.

  • The Sharp Story – Our Capabilities And Experience

    Sharp works collaboratively with pharmaceutical and biotechnology clients across the world to create unique commercial and clinical packaging solutions. We are a global leader in contract packaging solutions and clinical trial supply and manufacturing services. Together, our 1,800-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional reputation for the design, serialization and production of innovative packaging for even the most complex products.

  • Delivering Clinical Trial Medications Direct-To-Patient

    In a perfect world patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately that is not always the case. In recent years the Direct-to- Patient model, which brings medical procedures to a patient’s home, has emerged as a solution for Sponsors to increase patient recruitment and retention in clinical trials.

  • Inventory Management System - Choosing The Right Clinical Trial Solution For Distribution And Supply Optimization

    Using an IRT or IMS system can vastly improve the visibility, control and management of a clinical trial. What are the differences between them? Which solution is the most suitable for a given trial? This webinar will focus on how carefully examining clinical trial and protocol expectations will allow participants to choose the right solution for their clinical trials.

  • Considerations For Your First Clinical Trial

    For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. Tt is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

  • What Your CMO Needs To Know About Serialization And Aggregation

    In recent years, the global pharmaceutical industry has been under intense pressure to enhance the safety, security, and continuity of the supply chain. This has required drug manufacturers and a vast range of supply chain partners to work collaboratively to improve supply chain transparency. The goal is to be able to track, trace, and authenticate products, and to assure prescription drug supply from the manufacturer to the patient. Partnering with a CMO that has applied traceability, serialization and aggregation standards across its own operations promises business continuity and speed-to-market that translate to a competitive advantage.

  • VIA Capsule System ‒ Liquid Nitrogen-Free Shipping For Cell Therapy Logistics

    Realize a more controlled, assured and patient focused way of shipping cell and gene therapies with the VIA Capsule™ solution. Easily charge this liquid nitrogen-free system using electricity. Securely load the cell therapy using your defined process, and capture records digitally. Integrate activities across the manufacturer, courier, and clinic while maintaining an electronic record of the shipment conditions, location, chain of custody and identity. If needed, use the shipper for temporary cryogenic storage. When the patient is ready, wheel the shipper in.

  • Cell Therapy Logistics: Advanced Therapy Treatment Case Study

    This case study describes work the establishment and testing of a cryogenic logistics pathway for an allogeneic Advanced Therapy Medicinal Product (ATMP).