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.
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- 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
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Engineering Approaches To Respiratory Drug Delivery
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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A Solvent-Free, Fusion-Based ASD Manufacturing Process
Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.
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Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility
As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.
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Container Closure Integrity: A Risk-Based Approach
Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.
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The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions
Pharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.
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Leveraging Integration At Each Phase Of A Drug Delivery System Project
By forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.
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Managing Poor Solubility With Cutting-Edge Formulation Approaches
An increasing number of poorly soluble APIs are the cornerstone of cutting-edge therapies, necessitating equally complex formulation technologies to maintain or improve solubility and, ultimately, bioavailability.
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Why It Is Never Too Early To Consider Tungsten Interactions
A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.
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USP <382>: Think Systems, Not Components
This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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Successful Industrialization Requires Solid Foundations
Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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6 Packaging And Delivery Challenges For Biologic Therapies
In 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.

