Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.
- Does TSLP Inhibition Signal The Next Wave Of Respiratory Biologics?
- Nanosystems And Rare Diseases: Opportunities And Limitations
- 3 Emerging Trends In Drug Delivery Device Pipelines
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Closing The Adherence Gap: The Connected Health Era
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
- The Future Of Kidney Disease Therapeutics: Bringing Nanomedicine To Nephrology
- Injecting Cancer Killers: Intratumoral Therapy For Solid Tumors
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Understanding Of Amorphous Solid Dispersions & Their Downstream Development
Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
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Streamlining The Path To Market For Generic Drug-Device Combinations
Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1
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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Vial Adapter Considerations For Cell And Gene Therapy Applications
Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.
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Autoinjectors: A Revolutionary Leap In Drug Delivery
Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.
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Promising Early Results For New High-Performance DPI
This report discusses the benefits of the αeolus technology, a passive, high-performance, high-consistency dry powder inhaler platform concept, and the preliminary performance data from early-stage development.
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A Technical Package That Serves On-Time Injectable Project Completion
The accuracy, robustness, and completeness of the technical package an organization submits to its development and/or manufacturing partner is critical to meeting fill project timelines.
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Responding To Trends In Prefilled Delivery: Component Assessment And Selection
Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.
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Small-Scale Aseptic Filling Technology Considerations
Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.
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Driving Sustainability In Spray Drying Through Enabling Technologies
By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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6 Packaging And Delivery Challenges For Biologic Therapies
In this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.

