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
ON-DEMAND WEBINARS
Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
Discover how these groundbreaking Oral GLP-1 Analogs therapies are reshaping obesity management and addressing key challenges in formulation and delivery.
"One stop” sterile injectable fill/finish capabilities can accelerate timelines and reduce costs. Explore August Bio’s operational flexibility and available capacity to support small-, mid-size, and large-scale batches.
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Nanoparticles GettyImages-622777274]( "Unlocking New Possibilities For Treating Rare Genetic Diseases")
Unlocking New Possibilities For Treating Rare Genetic DiseasesWith over 7,000 rare diseases, the potential for nanomedicine to revolutionize treatment is immense. While polymer nanoparticles hold great promise, several challenges remain.
-
Gaps In Reconstitution Process Filled By Water-For-Injection Syringe
The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.
-
![Syringes GettyImages-171324030]( "5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes")
5 Ways Pre-Filled Syringes Contribute To Better Patient OutcomesIn our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.
-
![West-Labs 093_ASE-0111]( "Establishing And Safeguarding Shelf Life In Combination Products")
Establishing And Safeguarding Shelf Life In Combination ProductsEstablishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.
-
![GettyImages-1346675584-team-lab-research-development]( "Key Considerations For Emerging Companies When Selecting Packaging Components")
Key Considerations For Emerging Companies When Selecting Packaging ComponentsRecognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
-
![iStock-146792998-capsule-powder-pill]( "Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development")
Precision Powder-In-Capsule Micro-Dosing Accelerates Drug DevelopmentPrecision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
-
![GettyImages-1002000796-lab-research-scientist-development]( "Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials")
Functional Testing Summary Of Daikyo Crystal Zenith Nested VialsThe Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
-
![iStock-1319077865-lab-team-computer-research]( "Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk")
Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower RiskDiscover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
-
![Female scientist microscope-GettyImages-1453524892]( "Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products")
Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination ProductsLearn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.
-
![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.
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
-
![Delivered _by _DeGrazio_Logo_Color_2]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
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.
