Clinical Supply Packaging Resources
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Clinical Supply Optimization: Process Improvement Accelerates Trials
6/3/2022
A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.
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Lifecycle Planning For Containment And Delivery Of Biologics Drug Products
6/20/2024
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.
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Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change
3/9/2023
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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The Patient-Centric Clinical Supply Chain For Cell And Gene Therapies
8/1/2022
This article explores how delivering cell and gene therapies to patients requires new levels of agility, flexibility and innovation in the logistical management of supply.
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Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials
5/24/2024
The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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Overcoming Challenges In Cell And Gene Therapy Containment
Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
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Solving Logistic Complexities In The Era Of Personalized Medicine
1/1/2022
Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.
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Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures
2/26/2019
One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.
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Highly Potent, Perfectly Packaged
1/12/2023
Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.
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Building Robust Clinical Supply Chains To Support Global Trials
Ensuring drugs reach patients at the right time and place is crucial. Review key areas to consider as you build a robust clinical supply chain that supports global trials effectively and efficiently.