CLINICAL SUPPLY MANUFACTURING ARTICLES
Comparability Considerations For mRNA Product Development
Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.
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When it comes to transporting highly sensitive and valuable materials, such as cell therapies, learn how teams can ensure that unique storage and distribution requirements are met.
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A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.
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Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.
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The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.