We caught up with Davinder Ramsingh, MD, to talk about the potential of using low-intensity focused ultrasound (LIFU) to open the blood–brain barrier.
- 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- Unpacking The FDA Draft Guidance On Container Closure Systems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
- Inquiries In Inhalation, Part 2: Having A Nose For Innovation
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Avoiding The Pitfalls Of LNPs And Complex Formulations
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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Steps To Overcome Challenges Associated With Biologic Formulation Development
Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).
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FAQs On The Revised EU GMP Annex 1: Volume 7
Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.
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Nasal Inhalation Delivery – An Introduction Guide
Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.
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How A Flexible Approach To Autoinjector Assembly Can Be Advantageous
Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.
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Reducing Environmental Impact At All Stages Of The Medicine Journey
Explore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.
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A Smarter Strategy For Optimizing Oncology Drug Products
John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.
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Improve Solubility And Spray Drying Throughput For Brick Dust Compounds
This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.
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Designing Delivery Devices For Older Adults With Cognitive Impairment
Leverage our insights to improve your human factors studies and ensure the effective inclusion of older adults with mild cognitive impairment.
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Container Selection For A Highly Sensitive Drug Product: A Success Story
Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Unpacking The FDA Draft Guidance On Container Closure Systems
In 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.

