UK-based Cellexus Biosystems has announced that for the first time bacterial and mammalian cells grow efficiently in a disposable commercially available bioreactor.
The company explained that the driving force behind CellMaker Lite, was the biopharmaceutical industry itself and its desire to move towards disposable systems.
The increasing use of disposables in bioprocessing, a method that involves living cells becoming production units, is due to advantages disposables have in comparison with traditional units of glass and stainless steel.
These advantages include lowering capital, cleaning and validation costs. "
It takes an operator days to strip-down, clean, decontaminate, sterilise and then re-validate and document the validation of a traditional bioreactor.
The ability of a biopharmaceutical production facility to re-task a bioreactor to a new project, particularly at lower scale, is important, " Dr Kevin Auton, CEO of Cellexus Biosystems, told In-PharmaTechnologist.com.
" The drive to becoming more responsive and be able to manage ever changing project priorities are key motivators in the industry - as is constant drive towards cost reduction.
Disposable solutions enable these objectives to be achieved. "
The CellMaker Lite has no moving parts and is simple to manufacture.
The technology promises low investment cost, high performance, short turn-around times and ease of use, according to the company.
Cellexus has created an asymmetric "airlift" system that is used in combination with a disposable asymmetric bag (CellexusBag).
The main bulk of the cell culture volume is to be found at the bioreactor's top surface, which is where the largest surface area is to be found.
The system increases the aeration process 3-fold in comparison to other systems and also eliminates foam formation, known to reduce cell count viability. "
The results we have now achieved with both mammalian cells and bacterial cells, all grown within a disposable system, makes the CellMaker Lite a unique and compelling opportunity for the biopharmaceutical industry, " added Auton.
" Many researchers have commented that they think that the CellMaker technology will displace existing bioreactors.
Others have stated how pleased they were to see new technologies coming to a field in which there has been a lot of evolution but not much in the way of revolution, " concludes Auton.
Cellexus launched their patented CellMaker Lite last autumn in the UK and globally at the end of December.