For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.
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- 6 Packaging And Delivery Challenges For Biologic Therapies
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Learn about key product parameters affecting patient acceptability and therapy adherence and taste masking strategies, including organoleptic and barrier coating approaches and microencapsulation technologies.
Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.
Discover how these groundbreaking Oral GLP-1 Analogs therapies are reshaping obesity management and addressing key challenges in formulation and delivery.
The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2002525379-production-solid-dose-capsules]( "Patient Adherence With A Novel Dosage Form")
Patient Adherence With A Novel Dosage FormA sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.
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![GettyImages-1311494525 Vaccine Vials]( "2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance")
2R Vials And Deep Cold Storage - Determining Mechanical & CCI PerformanceReview the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.
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![West Pharma - Article 1 - 4040-40 Lyotec 13mm 20mm Group V2]( "Stopper Functionality – Key Considerations")
Stopper Functionality – Key ConsiderationsWhen selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.
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![DD 3 - PFS Grouping 002]( "Lifecycle Planning For Containment And Delivery Of Biologics Drug Products")
Lifecycle Planning For Containment And Delivery Of Biologics Drug ProductsRead more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.
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![GettyImages-597935610 cell and gene]( "Delivering The Promise Of Gene Therapy")
Delivering The Promise Of Gene TherapyGene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.
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![AST- ASEPTiCell ScreenShot 16]( "The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation")
The Future Of CDMOs: Aseptic Filling Solutions For Growth And InnovationThe rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.
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![GettyImages-1306440102-sterile-injectable-syringe]( "The Growth Of Sterile Injectables")
The Growth Of Sterile InjectablesLearn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Engineering Approaches To Respiratory Drug DeliveryExplore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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![GettyImages-950086574-oral-solid-OSD-pill-tablet-capsule-development]( "Choosing A Formulation And Process Approach To OCR Products")
Choosing A Formulation And Process Approach To OCR ProductsDo you want to develop an oral controlled release (OCR) product? Understand the options and their ramifications as the first step toward devising a plan.
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![iStock-843765220-pill-glove]( "Achieve Release Profiles And Select Excipients For Formulation Development")
Achieve Release Profiles And Select Excipients For Formulation DevelopmentThe formulation and manufacture of modified-release OSD forms are highly specialized. Review considerations for planning and executing a successful modified release oral solid dosage formulation.
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DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
