Articles, App Notes, Case Studies, & White Papers
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Achieving New Heights By Expanding Services, Talent, And Facilities
4/20/2023
As you aim to reduce costs and ensure on-time delivery, discover the opportunities for drug formulation and commercial supply that can advance your therapy to the clinic and beyond.
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Decoding the FDA Guidance on Essential Drug Delivery Outputs
2/18/2025
The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
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Unlocking Agility And Efficiency In Biomanufacturing
5/2/2025
Discover a standardized yet flexible modular biomanufacturing system designed to accelerate timelines, improve scalability, and enhance quality while reducing costs and environmental impact.
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Finding The Ideal Balance — Where Risk And Cost Of Quality Meet
10/6/2020
It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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Rational Design & Development Of Lipid- Filled Hard Capsules
1/26/2022
With the increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based drug delivery systems have become an important tool for formulation development.
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Using Advanced Technologies To Formulate Complex Molecules
In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.
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Principles Of Raman Spectroscopy And Application To Pharma Development
10/26/2020
Learn how Raman spectroscopy is used to analyze a chemical compound’s structure and examine an example of how this technique is used to analyze amorphous material created through hot-melt extrusion.
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The Importance Of A Human Centered Approach To Product Development
To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.
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Development And Scale-Up Of Insoluble, Microbially Expressed Biologics
Inclusion bodies, which are typically undesirable, are now gaining attention for their potential to produce a range of difficult-to-express proteins in E. coli systems.
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How Approved Drugs Have Evolved Since The '70s
Drugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.