The emergence of antibody–oligonucleotide conjugates (AOCs) addresses delivery issues with huge potential. Let's look at how to approach your development plan with molecular architecture, defining the target product profile, and CQAs.
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
- Engineering Better ADCs, Part 2: Characterization, CMC, And More
- What Patients Actually Want From Connected Drug Delivery
- Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery
ON-DEMAND WEBINARS
Discover highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM).
If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-517743436-plasmid-dna-development-lab]( "Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery")
Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals DeliveryLipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.
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![West1]( "Early Decisions To De-Risk The Transition To Combination Products")
Early Decisions To De-Risk The Transition To Combination ProductsThe injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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![Image 1]( "Start Packaging Development Early: De-Risk Before You Build")
Start Packaging Development Early: De-Risk Before You BuildWhen packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.
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![Simplify the journey]( "Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs")
Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic DrugsDevelopers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
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![Self injection med device GettyImages-1322057207]( "Overcoming Wet Injection Challenges With Human-Centric Design")
Overcoming Wet Injection Challenges With Human-Centric DesignBy 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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![Scientist in lab GettyImages-872025342]( "Harness High-Quality PBPK Modeling To Enhance Clinical Readiness")
Harness High-Quality PBPK Modeling To Enhance Clinical ReadinessPhysiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.
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![Artificial Intelligence (AI) Digital Concept GettyImages-1160995648]( "The Algorithm Is In: 5 Ways AI Is Transforming Medicine")
The Algorithm Is In: 5 Ways AI Is Transforming MedicineAI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.
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![Oct2020bucket]( "Leveraging Integration At Each Phase Of A Drug Delivery System Project")
Leveraging Integration At Each Phase Of A Drug Delivery System ProjectBy forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.
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![Three Lenses For Selecting An On-Body Platform_Ypsomed]( "Beyond Drug Delivery: Three Lenses For Selecting An On-Body Platform")
Beyond Drug Delivery: Three Lenses For Selecting An On-Body PlatformChoosing a wearable delivery platform goes beyond technical fit. Discover how performance, patient experience, development readiness, and lifecycle planning shape long-term success.
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![BO 2 - GC_App_^CZ vial with stopper and seal stack up]( "Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization")
Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To CommercializationWhile in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
