Bio-pharmaceuticals R&Ds are working with mammalian cell expression systems for developing mAbs and other therapeutic proteins. Scientists today are using increasingly smaller culture volumes grown in 10ml to 15ml micro bioreactor formats or even smaller volumes in 24 to 48 plate systems for clone and media optimization, cell line selection, small scale perfusion mimic and early process optimization. In these applications multiple cell harvests need to be clarified to remove cells and debris before the critical metabolite analysis/ chromatography steps. Conventional methods for clarification of such small volumes (few mL) are centrifugation followed by 0.2µm membrane filtration.
However centrifugation is a time consuming, cumbersome process and may also result in shearing of cells resulting in increased cell debris, cell organelles and intracellular proteins in the supernatant. The conventional syringe filter, although used for final filtration of the supernatant does not offer an efficient solution in terms of throughputs.’
Continue reading “One Step Sterile Harvesting of Mammalian Cell cultures in the lab”
Closed loop sterility testing systems have been successful in prevention of false positives while sterility testing of sterile injectables. However, there are special containers such as insulin cartridges (that fit into hand held delivery systems), wherein increased manual intervention is required for pooling the same into a 100ml vial before these can be transferred/filtered through the closed sterility test canisters. This increases the possibility of extraneous contamination and thereby false positives.
A syringe is used to draw the insulin sample from the specialized cartridge and is then pooled into a 100ml vial to be transferred/filtered through the sterility test canisters.
This involves multiple risks and cons such as:
- Chances of extraneous contamination, spillage and manual error
- Increased incidence of false positives
- Increased cost of operation and documentation
Continue reading “Prevent False Positives While Sterility Testing of Insulin Cartridges”