Precision oncology has transformed who receives treatment and what biology we target. The next frontier is designing where therapeutic activity occurs.
- Crossing The Uncrossable: Skin Biology For The Delivery Of Peptide And Protein Therapeutics
- When The Adhesive Becomes The Drug Delivery System
- Antibody–Oligonucleotide Conjugates, Part 1: Approaching Your AOC Development Plan
- Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
- Rethinking Drug Delivery To Combat Antibiotic Resistance
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
ON-DEMAND WEBINARS
Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.
Learn more about defining the spray drying process with an emphasis on specific enhancements to accommodate scale-up to commercial scale equipment of challenging applications or molecules.
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1453524887-scientist-in-lab-with-computer-and-microscope]( "POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization")
POC Diagnostics: 4 Considerations For Bridging The Gap From Development To CommercializationScaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.
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![West-BIO 1 - 88_NovaPureSyringes_0922]( "A Pathway For Regulatory Success For Devices In Combination Products")
A Pathway For Regulatory Success For Devices In Combination ProductsReady to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.
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![Cleanroom Scientists Using Tablet GettyImages-1341292153]( "High-Throughput Platform Propels Gene Editing Therapy Research")
High-Throughput Platform Propels Gene Editing Therapy ResearchExplore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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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-1284041821 asian vaccine]( "Elastomer Plungers With Barrier Film For COVID-19 Vaccines")
Elastomer Plungers With Barrier Film For COVID-19 VaccinesMinimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.
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![GettyImages-1371993517-syringe-vial-mask-vaccine-inject]( "A Lifecycle Management Strategy For Sterile Injectables")
A Lifecycle Management Strategy For Sterile InjectablesGain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
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![thinkstock_pharma_manufacturing_450x3001]( "Parenteral Packaging And Delivery Systems: Container Closure Integrity")
Parenteral Packaging And Delivery Systems: Container Closure IntegrityReview the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.
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![GettyImages-872019514-dna-gene-teach]( "Container Closure Integrity Evaluation For Cell And Gene Therapies")
Container Closure Integrity Evaluation For Cell And Gene TherapiesWith the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.
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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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![GettyImages-1291031560-lab-research-computer]( "5 Novel Techniques For Solubility Enhancement")
5 Novel Techniques For Solubility EnhancementThanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.
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]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
