How it’s used
Biopharmaceutical labs use osmolality testing as an in-process control and quality-check throughout development and manufacture of biologics. Osmolality testing helps ensure cell health, in-process reagent quality and helps reduce the risk of batch failures.
About osmolality in Biopharma
To ensure a quality manufacturing process is achieved, the use of process analytical technology (PAT) is recommended. Osmolality as a PAT can be used to monitor raw material components, process intermediates and finished products. Osmolality is a measure of solute concentration in process fluids and is considered a crucial quality attribute and critical value in bioprocessing.
Read all about this Freezing Point technology in Biopharma in the white paper Osmolality in Biopharma and application note Osmolality as a quality attribute in downstream processing. Both compiled by Advanced Instruments.
Osmolality and compliance:
what you need to know
Osmolality is a great tool in biopharmaceutical development. However the rules of using the equipment differ in the EU from the US. Key differences:
- The EU requires a zero point calibration for osmolality.
- The EU requires calibration using at least 2 reference solutions.
- The EU recommends to rinse the sample container with the solution to be tested.
In this blog Sjoerd Goote, Product Specialist I&L Biosystems BeNeLux, guides you through the rules and procedures.
Prevent your workflow from FREEZING
Do you recognize this? Your research is going well. The results are looking good and you are about to finalize your valuable work. But then you discover that your osmometer is dated and it does not comply with the adapted regulations. It even causes your workflow to become non-compliant. Your workflow reached its Freezing Point.
In this blog Peter van Doorn, Product Specialist at I&L Biosystems BeNeLux, tells you all the ins and outs about osmolality and its regulations and compliances. This way you can prevent your workflow from freezing and warm up your knowledge on osmolality.
Preserving data integrity: 21 CFR Part 11 compliance and osmolality as a process parameter
A collaboration of Advanced Instruments with Angela Bazigos, CEO of Touchstone Technologies Inc.
What you will learn:
- Explanation what data integrity is for pharma and biotech industry.
- Demonstrate how your analytical instruments can be 21 CFR part 11 and EU Annex 11 compliant for data integrity and electronic record management.
- Recognize the value of osmolality testing as a key process parameter in pharma and biotech industry and how it supports 21 CFR part 11 and EU annex 11 regulations.
Length: 55 minutes
Cell and gene therapy has come a long way in a short amount of time and there is a desire to identify ways to consistently improve manufacturing workflows. Osmolality offers not just one, but eight ways to build confidence in your bioprocess.
Length: 55 minutes
The Jefferson Institute of Bioprocessing (JIB) evaluated Advanced Instruments’ newest freezing point depression osmometer, OsmoTECH® XT, against vapor pressure technology to analyze mAb formulations & salt standards. Curious about the test results? Download the application note.
View OsmoTECH XT