Drug Development White Papers & Articles
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Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying
3/10/2023
A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.
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Match Your Development And Manufacturing Path To Your IND Milestones
2/17/2023
The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.
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Validating The Efficacy Of A Compound With Spatial Imaging
2/13/2023
Discover how target and efficacy validation can translate into substantial savings and market advantages for sponsors as a result of shortened development and approval timelines.
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Validated HPLC-UV Method For Quantification Of Paxalisib
1/18/2023
Examine research into the development and validation of a HPLC method for the quantitation of paxalisib in mouse plasma and its potential use for routine therapeutic drug monitoring.
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The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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Validated LC–MS/MS Method For The Determination Of Copanlisib
11/14/2022
Review study findings on a validated LC–MS/MS method for quantifying copanlisib from a mouse dried blood spot and its potential for enabling desirable sensitivity, accuracy, and precision.
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Biosafety Testing And Quality Control Requirements For Lentiviral Vectors
9/26/2022
Learn more about manufacturing principles of LV vectors as well as testing requirement regulatory considerations with a particular focus on the replication competent virus assay and infectious titer assay.
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Dwell Volume And Extra-Column Volume: What Are They And How Do They Impact Method Transfer?
9/22/2022
Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.
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Optimizing Lipid Formulations For Targeted RNA-LNP Applications
9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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Process Development Considerations For RNA-LNP Therapeutics
9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).