Next-generation orthobiologics could transform spinal fusion by enabling targeted bone regeneration, improving safety, and reducing reliance on traditional grafts and hardware.
- Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?
- Red Blood Cell-Based Delivery: Promising Steps Forward
- Stability And Release Testing For Delivery Devices: Waived Or Wanted?
- Microneedles In Drug Delivery: From Bench To Patch
- How Targeted Nanoparticles And Circular RNA Are Advancing CAR-T Development
- Beyond The Surface: Balancing Efficacy, Safety, And Patient Experience In Ophthalmic Delivery
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- Biomaterials In Ophthalmology Are Reshaping Ocular Drug Delivery
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation
The rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.
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Achieving EU GMP Annex 1 Compliance For Contamination Control
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
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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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Keys To Driving Consistent Quality In Contract Manufacturing
Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.
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Taking A Best Practice Approach To Contamination Control
Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.
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Meet Regulation Requirements With RTU Vials And Cartridges
Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.
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Improved Biomanufacturing Processes And Drug Product Stability
Improve upstream media for bioavailability and foam stability, downstream buffers for purification, and the formulation and final fill drug product stability with this highly interdisciplinary process.
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Effects Of Annex 1 Revisions On Manufacturing Operations
The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.
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FAQs On The Revised EU GMP Annex 1: Volume 8
Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.
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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.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing
In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.

