Articles, App Notes, Case Studies, & White Papers
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Key Considerations For Emerging Companies When Selecting Packaging Components
Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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Managing Refrigerated vs. Frozen Drug Product: What's The Big Deal?
The most common storage is ultra-low temperature storage, but the fastest-growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature and custody data is imperative.
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Key Considerations For Labeling Your Cell Or Gene Therapy
As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.
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Build A Foundation For Successful Clinical Manufacturing
5/8/2023
Establishing both the QTPP and CQA for your drug at the beginning of the product lifecycle is crucial for a successful GMP manufacturing process.
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Developing Injectable Drug Placebo Formulations For Clinical Trials
1/9/2024
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain
With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
5/12/2023
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments
3/1/2023
Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.
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Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C
This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.
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How Direct-To-Patient Models Can Provide Clinical Supply Chains With An End-To-End Solution
9/20/2021
Analyze the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency, and accelerate speed to market.