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Pharmaceutical Companies Can Optimize Enterprise Asset Management and Achieve Success
July 22nd 2024An integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.
Roles and Responsibilities of Specialized Clinical Supply Experts
June 21st 2024When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains. Having a team of individuals with specialized expertise in different areas of clinical supply—including protocol review and early operational planning, to managing the development and execution of a sound clinical supply strategy—can prove invaluable to the overall suitability and performance of the supply chain, and in turn, the successful execution of the study itself.
Critical Supply Strategies for CROs
June 21st 2024When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client. Additionally, once the CRO has been awarded the project and now must create an executable plan for managing the study’s complex clinical supply needs, there are one or more key decision influencers who are critical to engage early on during the planning and project set-up stage and several proactive steps to take to build a solid clinical supply plan.
Commercial Drug Sourcing for Clinical Trial
June 21st 2024The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Selecting the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.
QbCon®1 Twin Screw Granulator & Truly Continuous Dryer
June 19th 2024QbCon® 1 offers the optimal entry into continuous production. Our truly continuous wet granulator and dryer for research and development guarantees improved product quality while increasing flexibility and operator safety. It also reduces costs by using fewer resources and shortens development cycles by process analytics. Unlike competing systems, QbCon® 1 enables a permanent, truly continuous process without the formation of sub-batches and blocked filters.
Navigate your Efficient-Pro journey with professional support
June 10th 2024This asset outlines the comprehensive support and guidance offered by the FAS team for optimizing monoclonal antibody (mAb) manufacturing processes using the Efficient-Pro medium and feeds. Readers will learn about the tailored assistance provided at every stage, including troubleshooting, recommendations
Lab Logic: Decoding Analytical Testing for Optimal Product Development
June 10th 2024Biopharmaceutical companies are increasingly partnering with CDMOs equipped with technologies and expertise to support analytical testing during process development. The level of complexity required to develop and manufacture cell and gene therapies has increased, including the use of various raw materials, custom reagents, and tailored approaches for managing complex diseases.
Gibco Efficient-Pro Medium and Feeds Evaluation Guide
June 10th 2024The Gibco Efficient-Pro Medium and Feeds Evaluation Guide provides insights into enhancing monoclonal antibody manufacturing workflows. Offering improved titers, viability, and protein quality in CHO cell lines, it introduces a comprehensive evaluation process for maximizing productivity. Explore this asset for detailed step-by-step guidance and troubleshooting tips
Accelerate your mAb manufacturing workflow
June 10th 2024In this asset, you will discover how the Gibco Efficient-Pro system can revolutionize your mAb manufacturing workflow. It provides insights into optimizing CHO cell productivity, enhancing product titers and protein quality, streamlining process efficiency, and leveraging a reliable supply network.