Let's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
- 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?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Prioritize Safety And Mitigate Risk In HPAPI Manufacturing
As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.
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Platform Reduces Product Development Time And Cost By 30%
Using innovative capsule-filling equipment and processing technology, and mini-tablet and drug-layered beadlet manufacturing, you can have an adaptable, easily modified formulation.
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Liposome Vs. Lipid Nanoparticle: What's The Difference?
Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.
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Safeguarding Cell Therapy Cryopreservation: Primary Containers
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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Plan For Your Extractables And Leachables Studies To Meet Submission Timelines
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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Implementing Medium And High-Volume Drug Handling And Packaging Programs
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.
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Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations
Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
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Maintaining Drug Bioavailability And Masking Taste With Microencapsulation
Several technologies are available for microencapsulating drugs. Finding the right CDMO to optimize a drug’s efficacy and manufacturing during formulation is integral to its clinical and commercial success.
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Selecting A Strategic Partner For Your Combination Product
It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.
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The Gateway Delivery To The Brain
Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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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.

