CLINICAL SUPPLY MANUFACTURING ARTICLES
When In The Product's Life Cycle Does Continuous Manufacturing Make Sense?
This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.
CLINICAL SUPPLY MANUFACTURING RESOURCES
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In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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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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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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Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.
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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.
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Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
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Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.