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?
ON-DEMAND WEBINARS
Watch to hear Steven Facer, Adare's Vice President of Business Development EU/ROW, discuss the challenges of pediatric oral solid dose manufacturing and how to overcome them.
Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.
A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.
Led by Dr. Richard Johnson, Chief Scientific Officer, this 40-minute session covers the five key stages of the UpperNose development platform, highlighting the significance of target product selection and its influence on formulation and clinical outcomes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![sterile-injection-capsules]( "Collaborating With A CMO To Bring Your Sterile Injectable Product To Market")
Collaborating With A CMO To Bring Your Sterile Injectable Product To MarketReview considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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![iStock-1127257350-innovation-ideas-lightbulb]( "Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway")
Innovative Formulation Technologies By 505(b)(2) Regulatory PathwayRevitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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![West-PO 3 - GCApp]( "Meeting Annex 1: A Proactive Approach To Regulatory Compliance")
Meeting Annex 1: A Proactive Approach To Regulatory ComplianceIt 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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![GettyImages-1300035668-nanoparticle-particle]( "How Lipid Nanoparticles Overcome Solubility Challenges")
How Lipid Nanoparticles Overcome Solubility ChallengesMore than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.
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![West-NovaPure]( "Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems")
Moving From Vial Systems To Prefilled Syringes And Autoinjector SystemsMoving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
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![West-Ready Pack_006 LR]( "Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1")
Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.
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![GettyImages-1645853102-injectable-injection-self]( "Data-Driven Innovation Is Drug Delivery's Next Evolution")
Data-Driven Innovation Is Drug Delivery's Next EvolutionTo mitigate inherent risks like inconsistent dosing, user error, and low adoption due to complex usage procedures, technological innovation in delivery devices is best guided by lessons from the past, including user feedback and follow-on learnings from market data.
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![GettyImages-1220131127-pill-medicine-patient]( "Opioid Reformulation Filed As A CMC Supplement In Less Than A Year")
Opioid Reformulation Filed As A CMC Supplement In Less Than A YearSome reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.
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![GettyImages-1300035668-nanoparticle-particle]( "Exploring Lipid Nanoparticles For Drug Delivery")
Exploring Lipid Nanoparticles For Drug DeliveryUsing lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.
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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.
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]( "From Vial To Prefilled Syringe: Mastering The Development Transition")
From Vial To Prefilled Syringe: Mastering The Development TransitionIn 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.
