OCULAR DRUG DELIVERY ARTICLES
Regulating For Patient Safety And Success With Combination Products
At the AFDO/RAPS Combination Products Summit 2025, a notable focus emerged around approaches to risk assessment and human factors studies. In this article, Chief Editor Tom von Gunden offers his appreciation for the biopharma industry’s consideration of patient usability and safety in the development and regulation of combination products and other drug delivery devices.
OCULAR DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, lays out the phases and key activities in the development of a combination product or combination therapy. She underscores the importance of integrated development when merging medicinal product development with delivery device development.
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, outlines key management considerations for biopharma companies developing combination therapies. These include suppliers, partnerships, quality, container closure, and regulatory.
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, traces key conditions driving and impacting the development of advanced therapies and combination products. These include the demand for precision medicines, the complexity of regulatory frameworks, and pressures on healthcare systems.
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, highlights the promise of using combination products and combination therapies to reach difficult targets with precision. Carolyn notes crossing the blood-brain barrier as an example of a key therapy delivery advance.
OCULAR DRUG DELIVERY RESOURCES
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![GettyImages-851771510-eye-futuristic-scanning]( "Ophthalmic Drug Delivery")
Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.
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![GettyImages-525062561-syringe-vaccine-injection-subcutaneous]( "Rational Design And Development Of Long-Acting Injectable Dosage Forms")
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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![GettyImages-1069859094-IV-bag-intravenous]( "Mitigating Hidden Risks: Extractables And Leachables")
Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.
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![Nanoform]( "Small Is Powerful And Sustained")
Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.
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![GettyImages-1206035004-spectroscopy-lab]( "Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway")
Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
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![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
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![GettyImages-1398310603-Ophthalmology_Exam_Eye]( "New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology")
Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.
OCULAR DRUG DELIVERY SOLUTIONS
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![Scientist Using Tablet In Lab GettyImages-1354172577]( "PBPK Predictive Modeling Services")
Early identification of potential absorption risks is critical for rapid and efficient drug development. Lonza's PBPK modeling services are designed to de-risk your drug development program.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Pre-Filled Precision In Every Dose")
More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.
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![GettyImages-1133973940-immunoglobulin-cell-culture-antibody]( "Mammalian And Insect Cell Culture CDMO Services")
Early manufacturability assessments, complete cGMP solutions, and everything in between. FUJIFILM Diosynth Biotechnologies is a leading provider of cell culture services for biologics, advancing and delivering life-changing therapies.
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![GettyImages-1425605790 Life Sciences Training. Scientists Using A Computer In A Lab]( "Trusted Quality, Proven Expertise For Your Sterile Injectable")
Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable, powered by Pfizer’s global network of experts, reliability, and flexibility.
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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Unlocking The Potential Of Your Sterile Injectable")
Learn how a CDMO with robust processes and specialized technologies like automated fill lines can help you speed to market while maintaining consistently high quality of your product.
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![GettyImages-963804760-t-cell-cancer-cell]( "Allogeneic And Autologous Cell Therapy CDMO Services")
As a CDMO Partner for Life™, our goal is to advance your cell therapies from lab to commercial scale, leveraging our cell and gene therapy expertise and global cGMP network.
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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![adare]( "A Technology-Driven CDMO Delivering Integrated End-To-End Services")
Explore this interactive PDF with information about technologies & end-to-end integrated CDMO services provided by Adare Pharma Solutions.
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![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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![softgel]( "Find The Right Dosage Form To Suit Your Molecule")
Explore the importance of choosing the right partner to develop your Rx softgel drug.
