Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.
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ON-DEMAND WEBINARS
Intranasal drug delivery offers a promising route for administering medications, but advancing to market can be a difficult journey. Learn about common development pitfalls and how to mitigate risk.
Explore the role of solid form services in helping meet accelerated timelines of the drug development lifecycle along with examples of robust workflows for fast and thorough solid form screens.
Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.
Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Scientists In Lab GettyImages-1291031461]( "Is My Molecule Suitable For An Orally Disintegrating Tablet?")
Is My Molecule Suitable For An Orally Disintegrating Tablet?Innovations in drug delivery formats are enabling more patient-centric treatments and helping to boost patient compliance. Learn about the advances being developed to expand ODT technology.
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![iStock-1298328343-pill-tablet-bottle-prescription-OSD-oral]( "Key Offerings To Help Support Your OSD On Its Journey To Market")
Key Offerings To Help Support Your OSD On Its Journey To MarketExamine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.
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![West-BIO 1 - 88_NovaPureSyringes_0922]( "Achieving EU GMP Annex 1 Compliance For Contamination Control")
Achieving EU GMP Annex 1 Compliance For Contamination ControlGain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
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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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![Injection Vials GettyImages-125930642]( "The Importance Of Understanding Materials In Medical Product Development")
The Importance Of Understanding Materials In Medical Product DevelopmentExplore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.
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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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![Nasal Spray GettyImages-994129536]( "Key Considerations For Dry Powder Inhalation")
Key Considerations For Dry Powder InhalationA focus on spray-drying expertise in pulmonary and nasal powder development highlights why it is vital to choose the right CDMO.
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![GettyImages-1288978528 Scientist Using Microscope In Lab]( "A New Framework For Identifying Nitrosamine Risks And Derisking Products")
A New Framework For Identifying Nitrosamine Risks And Derisking ProductsExamine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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![Wooden blocks PFAS-GettyImages-2145498657]( "PFAS In Medical Devices: Expert Insights On Frequently Asked Questions")
PFAS In Medical Devices: Expert Insights On Frequently Asked QuestionsWatch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.
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![GettyImages-1044232264-team-lab-collaboration-teamwork-planning]( "Four Challenges That Stall Advanced Therapy Development")
Four Challenges That Stall Advanced Therapy DevelopmentMany challenges can stall an advanced therapy’s development. The vast majority of them are tied to inadequate preclinical planning and partner vetting.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
In her monthly column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "3 Lesser Known Keys To Effective Biopharma Supplier Engagement")
In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services.
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.
