A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
- Beyond Biologics: A Biophysical Approach To Crohn's Disease
- 6 Packaging And Delivery Challenges For Biologic Therapies
- Does TSLP Inhibition Signal The Next Wave Of Respiratory Biologics?
- Nanosystems And Rare Diseases: Opportunities And Limitations
- 3 Emerging Trends In Drug Delivery Device Pipelines
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Closing The Adherence Gap: The Connected Health Era
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
ON-DEMAND WEBINARS
High concentration formulations often present challenges with regard to viscosity as well as potential changes in the behavior upon stability. Discover solutions to mitigate high viscosity.
See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.
Ensuring medication adherence in pediatric patients presents challenges for pharmacotherapy. Explore various dosing solutions and learn how to streamline your pediatric development journey.
Discover highly promising in-vivo data, enabled by a nanoformed drug product for the treatment of glioblastoma multiforme (GBM).
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Syringes GettyImages-171324030]( "Key Trends And Developments In Injectable Drug Formulation And Delivery")
Key Trends And Developments In Injectable Drug Formulation And DeliveryAs the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.
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![Syringes GettyImages-171324030]( "Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation")
Stainless Steel Needles: Quantifying Cobalt Risk For EU RegulationLearn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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![GettyImages-693887284-vial-bottle]( "Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications")
Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy ApplicationsA study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.
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![GettyImages-1368429013-vial]( "Overcoming Challenges In Cell And Gene Therapy Containment")
Overcoming Challenges In Cell And Gene Therapy ContainmentReview the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
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![iStock-1045448388-oligonucleotide-PCR]( "Navigating Regulatory Challenges In Oligonucleotide Therapeutics")
Navigating Regulatory Challenges In Oligonucleotide TherapeuticsOligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
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![West-Production_Faility]( "Successful Industrialization Requires Solid Foundations")
Successful Industrialization Requires Solid FoundationsLearn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.
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![05 West]( "Leachables Method Development, Validation And Relevant ICH References")
Leachables Method Development, Validation And Relevant ICH ReferencesIt is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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![respiratory]( "Trends In Combination Products")
Trends In Combination ProductsAs demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.
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![West]( "USP <382>: Think Systems, Not Components")
USP <382>: Think Systems, Not ComponentsThis blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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![GettyImages-1346675584-team-lab-research-development]( "Key Considerations For Emerging Companies When Selecting Packaging Components")
Key Considerations For Emerging Companies When Selecting Packaging ComponentsRecognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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]( "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.
