Contract Pharma Manufacturing White Papers & Articles
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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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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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Expediting Early-Phase Development Of Small Molecules: An Integrated Approach
11/1/2022
Small molecule APIs and drug products are more complex and potent than ever. Explore key strategies for efficiently advancing small molecules from API to pre-clinical data and clinical supply.
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Key Considerations In Large-Molecule Orphan Drug Development
10/26/2022
Explore guidance for overcoming challenges with orphan drugs and ensuring that enough high-quality data is generated from the start of your program to guide evidence-based decision making.
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Tech Transfers: Optimize Success And Mitigating Risk
10/4/2022
Gain direction for ensuring successful technology transfers by understanding how to identify common challenges and find case-based solutions and best practices for overcoming them.
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The Future Of The FDA: Operating In An “Electronic World”
7/6/2022
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development
6/1/2022
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
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Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing
6/1/2022
Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
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Patient-Centric Oral Solid Dose Formulation
5/17/2022
Gain insight into the systematic application of patient centricity to the design of OSD products.
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Continuous Manufacturing And Late-Phase Strategy: The Time Is Now
5/17/2022
Explore recent progress in continuous manufacturing and guidance for answering key questions related to implementation of continuous processing for late-phase development.