A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
- Beyond Biologics: A Biophysical Approach To Crohn's Disease
- 6 Packaging And Delivery Challenges For Biologic Therapies
- Does TSLP Inhibition Signal The Next Wave Of Respiratory Biologics?
- Nanosystems And Rare Diseases: Opportunities And Limitations
- 3 Emerging Trends In Drug Delivery Device Pipelines
- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
- Closing The Adherence Gap: The Connected Health Era
- Delivery Strategy For Next-Gen Cardiac Gene Therapies
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Improving Toxicology Testing For Inhalation Products
By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.
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Design And Packaging Advantages For Cell And Gene Therapy Drugs
With the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.
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Exploring Lipid Nanoparticles For Drug Delivery
Using lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.
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Drug Formulation Development: Quick Reference Guide
This 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.
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Closing The Care Gap: Clinician Assistive Technologies
This technology addresses workforce shortages and growing medical complexity by helping healthcare providers manage rising demands, improve efficiency, reduce errors, and extend care access.
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Parenteral Packaging And Delivery Systems: Container Closure Integrity
Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.
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Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems
Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
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A Robust Extractables Data Package Helps Drive Patient Safety
Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.
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Innovative ASD Technology Improves Abandoned Cancer Medication
Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.
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Reducing Environmental Impact At All Stages Of The Medicine Journey
Explore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.
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.

