Articles, App Notes, Case Studies, & White Papers
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Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing
9/9/2022
This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.
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The Regulatory Compass Driving Drug Delivery Innovation
8/12/2026
Regulatory requirements are growing more complex. Discover how strategic planning, regulatory intelligence, and platform approaches can streamline development and approvals.
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Sample Sizes For Performance Testing Of Combination Products, Packaging
5/16/2025
When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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Overcoming Wet Injection Challenges With Human-Centric Design
6/19/2024
By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
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How To Find The Right Balance In Cell Therapy Manufacturing
5/20/2024
The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.
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FAQs On The Revised EU GMP Annex 1: Volume 2
3/5/2025
Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.
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Reducing Lead Time & Optimizing Costs
8/2/2022
Explore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.
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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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USP <788> Revisions And Why Packaging Matters More Than Ever
5/12/2026
Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.
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Capsule Formulation Development: From Dosage Forms To Filling
5/4/2022
Capsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.