Emerging therapies are being designed to safely deliver oligonucleotides to disease-relevant tissues. Delivery is no longer a technical hurdle to overcome but a strategic lever.
- PLGA: A Workhorse Polymer Behind Modern Depot Long-Acting Injectables
- Designing Nanoparticles: Why Size Comes First
- Why Operational Readiness Is The Missing Piece In Biosimilar Adoption
- From Vial To Prefilled Syringe: Mastering The Development Transition
- Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics
- Can We Cure Diabetes?
- Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
- Delivery Device Functional Scrutiny: Can You Pass (Without) The Test?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Meeting Annex 1: A Proactive Approach To Regulatory Compliance
It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
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Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products
IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
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Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations
The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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Recent Innovations And Enhancements To Pharmaceutical Spray Drying
Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.
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Robotics And AI In Pharma: Driving The Next Wave Of Innovation
Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.
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What's Next For NAMs? Moving From Barriers To Breakthroughs
The future of NAMs depends on robust biology, standardized practices, and submission-ready evidence that demonstrates value and strengthens regulatory trust.
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Enabling Long Lasting Clinical Outcomes In Coronary Stenting
Polyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).
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Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs
An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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Delivering On GLP-1 Demand: Combining Device And Supply Strategy
Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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From Vial To Prefilled Syringe: Mastering The Development Transition
In this article, Fran DeGrazio discusses the opportunities, challenges, and benefits for biopharmaceutical product developers in transitioning from vial-based to prefilled syringe (PFS) delivery approaches. She lays out key differences and added complexities in areas such as device functionality, risk management, regulatory pathways, use of materials, lifecycle management, and organizational alignment.
FREE EBOOK
Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.

