The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
|Webcasts|September 16, 2020
Non-destructive Moisture Determination for Lyophilization Process Development and Product Quality Testing
Author(s)Lighthouse Instruments
***Live: Wednesday, Oct. 21, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST*** Non-destructive moisture determination of freeze-dried product saves valuable samples and enables efficient robust data generation supporting lyophilization cycle development and freeze-dryer qualification activities. Join this webcast to hear case study data demonstrating these applications. ***On demand available after final airing until Oct. 21, 2021***
Register free:
Event Overview:
Determining the residual moisture content of a lyophilized pharmaceutical product is important for several reasons. First, the amount of residual moisture content is related to the stability of the formulation over the shelf life of the product. Second, moisture analysis of a statistically relevant sample set can give insight into the freeze-drying process itself.
Residual moisture determination can be used as a tool in process studies to confirm the efficiency, consistency, and robustness of a specific freeze-drying cycle that has been designed for a particular drug formulation. Unfortunately, the destructive nature of the traditional moisture determination methods (Karl Fischer titration and thermogravimetric methods) is a limitation that can lead to increased costs and limited insight into the stability and quality of freeze-dried product and drying cycles. Non-destructive moisture analysis can enable:
- Efficient analysis of statistical sample sets
- Ability to design and qualify drying processes in a less costly and more efficient manner based on robust statistical data
- Ability to directly correlate moisture to other critical product quality parameters
Key Learning Objectives:
- Learn how to use non-destructive headspace analysis for the moisture determination of freeze-dried product.
- Review case-study data showing how the headspace analysis approach to moisture determination enables lyophilization chamber moisture mapping, efficient lyophilization cycle development, and freeze-dryer performance qualification.
- Learn how this moisture analysis technique can be seen as a water activity measurement with general application to all dry pharmaceutical products.
Speaker: Dr. Derek Duncan, Director Product Line, Lighthouse Instruments
Time and Date: Wednesday, Oct. 21, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
On demand available after final airing until Oct. 21, 2021
Sponsor: Lighthouse Instruments
Register free:
Related to this article
The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
Shadow AI and vendor data retention put GMP records and trade secrets at risk. AI Pulse Check panelists outline what pharma AI policies require.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.