Clinical Supply Packaging Resources
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Understanding Injectable Drug Container Closure Systems
6/20/2024
Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.
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Outsourcing Your Highly Potent Oncology Drug Product
4/6/2023
Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.
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FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies
FDA requires packaging and distribution systems to protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
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Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change
3/9/2023
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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Packaging And Containment: Get Your Products To Market Faster
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 Dual Sourcing Approach
11/17/2022
Having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.
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Key Considerations For Selecting Fill/Finish Manufacturing Technologies
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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Desired Integrated Clinical Logistics Activities
8/15/2022
Learn why clinical labeling, clinical supply chain management, and storage and distribution of clinical trial materials received the most votes in a survey of 100 sponsors outsourcing clinical logistics.
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Safeguarding Cell Therapy Cryopreservation: Primary Containers
5/20/2024
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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GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm
8/15/2023
Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.