OCULAR DRUG DELIVERY ARTICLES
7 Management Strategies For Combination Product Regulatory Success
In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success.
OCULAR DRUG DELIVERY VIDEOS
In this videocast episode, host Tom von Gunden discusses Chapter 14 of The Combination Products Handbook (CRC Press) with the book’s editor Susan Neadle, along with chapter coauthors Stephanie Goebel, Cherry Malonzo Marty, and Viky Verna. The group provides overviews of the commonalities and variances in regulatory definitions and guidances for combination products across global jurisdictions and agencies.
In this episode of Supplier Horizons, host Tom von Gunden talks with Chief Commercial Officer Christian Jones of nanoparticle technology developer Nanoform about innovation in drug and biologics delivery. The discussion covers aspects of patient centricity such as aging populations, in-home self-administration, and personalized medicine. It also focuses on the use of nanotechnology in the delivery of high concentration formulations via oral and subcutaneous routes of administration.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 12 on biologics delivery with chapter author Manfred Maeder and the book’s editor, Susan Neadle. Manfred and Susan comment on the challenges of moving large molecule formulations into combination products while considering product stability, usability, and supply chain.
In this episode of In Combination, the technical leadership team from device consultancy Suttons Creek joins host Tom von Gunden to discuss trends in the patient landscape driving innovation in drug delivery, including combination products and therapies. The conversation covers patient self-administration, emerging modalities, and key considerations in product development, regulatory pathways, and the supply chain.
OCULAR DRUG DELIVERY RESOURCES
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![gettyimages-471932801-170667a]( "Pharmaceutical Nanotechnology: What To Know")
Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.
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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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![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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![GettyImages-533059254-mRNA_DNA_gene_therapy]( "Combining Gene Therapies, Carrier Systems, And Medical Devices")
Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.
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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-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.
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.
