In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions.
- Benchmarking RNA Delivery Performance: Toward Standardized Metrics For Translational Success
- Rethinking Product Development Through Lipid-Based Formulations
- Overcoming Lung Tumor Barriers: Nanoparticle Delivery Strategies For Pulmonary Cancers
- Advances In Endometrial-Targeted Drug Delivery In Women's Health
- RNA Delivery Technologies: Industrial Applications And Emerging Innovations
- Why In Vivo Therapies Fail When We Treat Them Like Ex Vivo Ones
- 4 Opportunities For Advancing Drug Delivery
- In Vivo's Biggest Threat — Comparison To Old Models
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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.
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Crystallization Process Development: Peptide Crystallization
Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.
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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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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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Formulation Research Strategy For Discovery- Stage New Drug Candidates
Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.
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Is Your Combination Product Drug-Led Or Device-Led?
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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FAQs On The Revised EU GMP Annex 1: Volume 8
Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.
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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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Finding The Ideal Balance — Where Risk And Cost Of Quality Meet
It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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Reliable Components For The Lifecycle Of Your Injectable Drug Product
As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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4 Opportunities For Advancing Drug Delivery
In this article, Fran DeGrazio identifies four prime opportunities for drug delivery developers to move the dial of innovation into 2026 and beyond. These avenues for advancement include diagnostics, patient tolerability, microdosing, and analytical methodologies.

