Outsourced Pharma White Papers
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Partnering With Clinicians To Improve Pediatric Formulation Development
6/13/2022
Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
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Direct-To-Patient Supply: Industry Perception And Future Trends
5/5/2022
To better understand sponsors’ perspectives on DTP distribution of clinical supplies, 234 individuals involved in clinical supply and operations were recently surveyed. Click to get the results!
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Development And Regulation Of Veterinary Monoclonals
2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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Controlling Trace Impurities In Chemically Defined Media
4/10/2023
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.
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Expectations On The Pathway To GMP For Gene-Modified Cell Therapies
6/21/2023
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
2/24/2023
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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Spray Drying To Enable New Inhaled Drug Products
7/11/2023
The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
8/14/2023
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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Extended Head Flats Increase Dwell Time
4/25/2024
Explore the extended head flat and how this punch modification can improve the compression of difficult formulations.