Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
- From Exosomes To Nanodrugs: Advancing Therapeutic Delivery For CNS Repair
- Risk Is the Spine: What The First 100 QMSR Inspections Reveal
- Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss
- The Hidden Operational Complexities Of Home Infusion
- 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
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Reducing Lead Time & Optimizing Costs
Explore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.
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Advances In Spray Drying For Enhanced Bioavailability And Improved Formulation Control
In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.
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Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform
Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
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Unlocking The Promise Of NAMs
Human-relevant models are reshaping safety and efficacy decisions, but impact depends on selecting the right tools, integrating evidence, and turning complex data into clear, decision‑ready insights.
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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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Q&A: Navigating PFAS In Medical Devices
Explore how PFAS in medical devices pose environmental and health concerns, prompting regulatory scrutiny.
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Vial Containment Systems Based On Elastomer 4031/45 Gray
Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS
Outlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, such as biologics and vaccines, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership with a flexible CDMO is the key to success.
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Liquid Capsule Manufacturing: What To Know
Capsules surround a drug in an unflavored, solid barrier enclosure. This article focuses on liquid capsule manufacturing and its advantages.
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Formulation Development Strategy For Early Phase Human Studies
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing
In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.

