Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
|Articles|September 2, 2016
- Pharmaceutical Technology-09-02-2016
- Volume 40
- Issue 9
Analyzer Automates Cell-Culture Chemistry Analysis
The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
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The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems. The system incorporates Nova’s MicroSensor Card technology, which minimizes sensor maintenance. The FLEX 2 provides analysis of 16-cell culture chemistries including Gluc, Lac, Gln, Glu, NH4+, Na+, K+, Ca++, pH, pCO2, pO2, osmolality by freezing point depression, and total and viable cell density and viability by trypan blue dye exclusion method. The full panel of tests can be run in under four minutes with 265 microliters of sample, and users can select from manual sampling or two modes for batch sampling: 96-well plates or the built-in 24-position tray. Designed for small volume, early-stage cell culture development through GMP manufacturing, BioProfile FLEX 2 provides 21 CFR Part 11 compliance, OPC connectivity, full networking functionality, and support with all validation needs.
Articles in this issue
about 10 years ago
The Internet of Things for Pharmaceutical Manufacturingabout 10 years ago
How to Get the Most Out of Facility Renovationsabout 10 years ago
Root Cause Analysis–Finding the Root of the Problemabout 10 years ago
New Directions in Modular Manufacturingabout 10 years ago
Efforts Accelerate to Streamline Postapproval Change Processabout 10 years ago
Common Deficiencies in ANDAs for Dermatologic Drug Productsabout 10 years ago
Maintaining Hygienic Diaphragm Valvesabout 10 years ago
Tumble Blenders Include Improved Safety Featuresabout 10 years ago
Data Logger Provides Ultra-Low Temperature Readingsabout 10 years ago
Liquid Handling System for Automatic Particle CharacterizationAdvertisement
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