Articles, App Notes, Case Studies, & White Papers
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Emerging Biopharm Rapidly Sets Up Phase 1 Oncology Trial
1/16/2024
Uncover how an emerging biopharmaceutical company was able to expedite the initiation of a Phase 1 oncology trial for a novel treatment targeting relapsed/refractory multiple myeloma.
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Optimized Laboratory Kitting Is Key To Successful Clinical Trials
5/18/2022
Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.
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Controlling Complexity (Not Cost) Of Advanced Therapy Supply Chains
Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.
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Consolidating Clinical Supply Chain Operations With GxP Inventory
4/18/2024
A Japan-based biotechnology company leveraged Signant SmartSignals® GxP Inventory, which improved visibility, reduced risks and costs, and optimized operations in this case study.
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Outsourcers Are Feeling Uneasy About Continuity Of Supply
4/14/2022
Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
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Logistics In Cell Therapy: Reducing Workflow Risk
6/19/2023
Explore key steps that should be taken when executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention.
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Planning Your Packaging For A Seamless Transition From Clinic To Launch
7/19/2022
Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.
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Investigational Medicinal Products: Labeling Changes And Their Implications
12/16/2022
Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.
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Sponsor Overcomes Hold And Steers Products Through Development
11/2/2023
Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.
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Faster From Formulation To Fill/Finish
7/12/2022
Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.