For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.
- A Case Study: Control Strategies For A Multi-Dose Pen Injector
- Control Strategies For Injectable Drug Delivery Combination Products
- From IV To Subcutaneous: It's Not About Convenience, It's About System Design
- 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
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology
Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.
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Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs
An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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A Glass Package Designed Specifically for Pharmaceutical Use
A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.
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How To Ensure Correct Component Selection When Outsourcing To A CMO
A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.
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Partnering For Success In Sustained Drug Delivery Formulations
With a focus on the sustained and controlled drug delivery segment of the pharmaceutical market, learn about technology platforms, support services, and sustainable solutions.
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Opioid Reformulation Filed As A CMC Supplement In Less Than A Year
Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.
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Accelerating The Development Of Oncology Medicines
Oncology drug development has seen a significant shift in focus, as molecule chemistries and drug technologies have improved. Explore five areas for consideration and the potential emerging solutions.
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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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Unlocking New Possibilities For Treating Rare Genetic Diseases
With over 7,000 rare diseases, the potential for nanomedicine to revolutionize treatment is immense. While polymer nanoparticles hold great promise, several challenges remain.
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Container Closure Integrity: A Risk-Based Approach
Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.
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.

