Articles, App Notes, Case Studies, & White Papers
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10 Ways To Align Your Medical Device With Human Factors Industry Best Practices
3/1/2024
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1
2/4/2026
Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.
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Reduce Costs And Improve Adherence For Self-Administration Of Biologics
There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy.
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Integrated Strategies for Achieving Regulatory Milestones Faster
10/12/2023
Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.
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Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products
3/7/2024
Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.
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Engineering Approaches To Respiratory Drug Delivery
5/27/2022
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations
7/12/2022
Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
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Key Offerings To Support Your OSD On Its Journey To Market
Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.
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Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
3/24/2023
Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market
2/15/2023
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.