The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- Surgical Therapeutic Design: Key Considerations In Formulation And Delivery
- Need A Drug Delivery Conversation Starter? Try Target Product Profile
- When Software Becomes Part Of The Medicine
- Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
- Treatment Adherence And Designing Therapeutics To Meet Patient Needs
- Complaints Into Practical Action: Human Factors Drug Delivery
- Human Factors: A Key Factor In Regulatory Approvals
ON-DEMAND WEBINARS
Explore how PEG selection shapes drug development success by understanding the benefits of expert CDMO partnerships that deliver custom solutions to enhance your small molecule program.
Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.
Ensuring medication adherence in pediatric patients presents challenges for pharmacotherapy. Explore various dosing solutions and learn how to streamline your pediatric development journey.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1156884561-fill-finish]( "Key Considerations For Selecting Flexible Fillers")
Key Considerations For Selecting Flexible FillersFlexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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![iStock-827581062-lab-computer]( "An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals")
An Elegant Solution For Delivery Of Acid Sensitive PharmaceuticalsSustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.
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![West]( "Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform")
Selecting A Vial Container Closure System With The DeltaCube™ Modeling PlatformUnderstand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
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![Pharma Manufacturing GettyImages-1135140594]( "Innovative ASD Technology Improves Abandoned Cancer Medication")
Innovative ASD Technology Improves Abandoned Cancer MedicationReview this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.
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![GettyImages-1353123922-doctor-patient]( "Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls")
Why 'Off-The-Shelf' Devices Do Not Circumvent Design ControlsUtilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.
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![GettyImages-1346675635-lab-tablet-research-team]( "Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations")
Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination FormulationsDr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
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![West]( "FAQs On The Revised EU GMP Annex 1: Volume 3")
FAQs On The Revised EU GMP Annex 1: Volume 3The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
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![GettyImages-1330728771-microscope-lab]( "De-Risking Visible Particles Through Component Selection")
De-Risking Visible Particles Through Component SelectionExplore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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![GettyImages-1346675513 lab materials]( "Early Solid Form Screening To Guide Drug Development")
Early Solid Form Screening To Guide Drug DevelopmentConducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road.
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![GettyImages-1203324464-decision-arrow-target-goal]( "Guidelines For Selecting A Medical Device Contract Manufacturer")
Guidelines For Selecting A Medical Device Contract ManufacturerConsider these guidelines when evaluating potential device contract manufacturers to choose one that will be the best fit for your company.
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.
