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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Design Success Combined With Expertise In Testing And Raw Material Selection
Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
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Formulation Development From Preclinical To First-In-Human
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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5 Novel Techniques For Solubility Enhancement
Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.
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Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations
Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.
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Improve Speed To Market By Mitigating Vial And Stopper Incompatibility
These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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Advances In Spray Drying For Enhanced Bioavailability And Improved Formulation Control
In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.
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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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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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Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
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Semi-Solid And Semi-Liquid Dosage Forms: What To Know
Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.
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.

