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.
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
- Surgical Therapeutic Design: Key Considerations In Formulation And Delivery
- Need A Drug Delivery Conversation Starter? Try Target Product Profile
- 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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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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How DFM Promotes Scalability, Repeatability, And Profitability
Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.
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Container Closure Integrity Evaluation For Cell And Gene Therapies
With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.
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Streamlining Primary Container And Device Selection With Predictive Calculations
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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Comparing Vial Container Closure Systems
Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.
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Outlining The Trends And Challenges In The Inhaled Drug Delivery Market
Explore the latest trends and solutions in inhaled drug delivery, with a focus on overcoming dry powder formulation challenges to advance next-generation therapeutics.
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How Various Clinical Study Stages Influence Oral Formulation Approach
It’s important for pharmaceutical and biopharmaceutical companies to implement a phase-appropriate approach for early formulation development and later-stage commercial development.
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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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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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Taste Masking 101: Optimize Taste And Improve Patient Outcomes
Taste masking is integral for a drug product’s final formulation. It can serve to increase patient acceptability and adherence to a therapy, in turn bolstering regulatory acceptance and commercial potential.
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.

