Conventional antibiotic prophylaxis often fails to maintain therapeutic levels at the surgical site over time; controlled-release local antibiotics can solve this.
- 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
- Regulatory Attention To Human Factors: How Much Is There?
- Gaining An Edge In GLP-1 Production
- Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction
- Where Drug Delivery Falls Short And What The Industry Should Do Next
ON-DEMAND WEBINARS
Learn how techniques and innovations in taste masking sensory and performance evaluation can help accelerate your formulation development and confirm desired taste profile.
What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.
Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
Drug Formulation Development: Quick Reference GuideThis guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
-
![Patent Trolls]( "The Largest LOE Event In US Pharma History")
The Largest LOE Event In US Pharma HistoryAhead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
-
![GettyImages-1368429013-vial]( "Overcoming Challenges In Cell And Gene Therapy Containment")
Overcoming Challenges In Cell And Gene Therapy ContainmentReview the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
-
![Assessing And Navigating Testing For Parenteral Packaging And Delivery Systems: Performance Testing]( "Best Practices For Ensuring Quality In Biologic Products")
Best Practices For Ensuring Quality In Biologic ProductsNew biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes.
-
![iStock-842481112-child-medicine-tablet-capsule]( "Age-Appropriate Pediatric Formulation Development")
Age-Appropriate Pediatric Formulation DevelopmentThere is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.
-
![GettyImages-1219894348-lab-cleanroom-PPE]( "Prioritize Safety And Mitigate Risk In HPAPI Manufacturing")
Prioritize Safety And Mitigate Risk In HPAPI ManufacturingAs 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.
-
![nanoparticles_updated]( "Liposome Vs. Lipid Nanoparticle: What's The Difference?")
Liposome Vs. Lipid Nanoparticle: What's The Difference?Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.
-
![West-BIO 1 - 88_NovaPureSyringes_0922]( "A Pathway For Regulatory Success For Devices In Combination Products")
A Pathway For Regulatory Success For Devices In Combination ProductsReady to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.
-
![West-Vol 7-Blog]( "FAQs On The Revised EU GMP Annex 1: Volume 7")
FAQs On The Revised EU GMP Annex 1: Volume 7Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.
-
![respiratory]( "Trends In Combination Products")
Trends In Combination ProductsAs demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.
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]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn 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.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
