Platform selection for long-acting injectables is increasingly complex because therapeutic modalities, delivery systems, and target product expectations have all diversified. Can your selected platform meet the needs of your product?
- Oral Combination Therapies: Navigating Development Complexities
- Beyond GalNAc: Reengineering siRNA For Extrahepatic Delivery
- Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases
- The Future Of Cancer Drug Discovery Is Targeted Immune Activation
- Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
- Unpacking The FDA Draft Guidance On Container Closure Systems
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
- Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics
ON-DEMAND WEBINARS
Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.
Explore how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.
Discover how aligning packaging strategy with technology transfer requirements can accelerate timelines, control costs, and support successful injectable drug product manufacturing.
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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![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-471932801-170667a]( "Pharmaceutical Nanotechnology: What To Know")
Pharmaceutical Nanotechnology: What To KnowHere is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.
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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
Improve Speed To Market By Mitigating Vial And Stopper IncompatibilityThese studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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![GettyImages-627023398 clinical lab]( "Navigating PFAS \"Forever Chemicals\" In Medical Devices - What's On The Horizon")
Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The HorizonGain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.
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![GettyImages-2199680273-lab-computer-scientist-in-lab-coat]( "Cartridge Filling: Where Precision, Process Control, And Experience Matter")
Cartridge Filling: Where Precision, Process Control, And Experience MatterCartridge drug delivery demands strict controls to guarantee dose accuracy. Early development and testing eliminate variability, prevent defects, and protect patient safety.
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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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Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges
An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.
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![Wooden blocks PFAS-GettyImages-2145498657]( "Q&A: Navigating PFAS In Medical Devices")
Q&A: Navigating PFAS In Medical DevicesExplore how PFAS in medical devices pose environmental and health concerns, prompting regulatory scrutiny.
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![GettyImages-1300035668-nanoparticle-particle]( "How Lipid Nanoparticles Overcome Solubility Challenges")
How Lipid Nanoparticles Overcome Solubility ChallengesMore than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.
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![Doctor Preparing Injection Site GettyImages-1379313214]( "Enabling Subcutaneous Delivery For Improved Patient Compliance")
Enabling Subcutaneous Delivery For Improved Patient ComplianceThe ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.
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]( "Unpacking The FDA Draft Guidance On Container Closure Systems")
Unpacking The FDA Draft Guidance On Container Closure SystemsIn this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
FREE EBOOK
Why Human Factors Are Critical To Drug Delivery Device Success
In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.
This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.
