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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5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes
In 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.
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Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies
A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.
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Using 505(B)(2) To Streamline Approval Of Combination Products
In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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Maintaining Sterility Through Precise Component Design And Manufacture
Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.
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Designing Delivery Devices For Older Adults With Cognitive Impairment
Leverage our insights to improve your human factors studies and ensure the effective inclusion of older adults with mild cognitive impairment.
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Crystallization Process Dev: Ramping Up Bench-Scale Control
Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.
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Overcoming Wet Injection Challenges With Human-Centric Design
By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
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Overcome Common Pre-Filled Syringe Challenges Through Partnership
The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.
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Impact Of Post-Covid Literacy Decline On Medical Device Studies In Youth
Examine the challenges of using traditional human factors methodology with young individuals whose literacy levels have declined compared to historical data.
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Development Of Next Gen Sustained Release Solutions For Pain Management
A TheraPEA™ polymer based injectable formulation designed to deliver the same dose of Triamcinolone Acetonide (TAA) as in Zilretta® has shown promising results in a series of pre-clinical studies.
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.

