GEA, a systems supplier for the pharmaceutical industry, has debuted a perfusion disc separator for the continuous production and faster processing of biopharmaceutical cell harvesting.
No more CIP and SIP cleaning
The novel separators in this series offer the same advantages as classic disc separators for fed-batch processes, though CIP and SIP cleaning isn’t necessary with this technology, meaning the machine can be ready for the next process run in a few minutes.
They also require no other media than electricity and air supply and can operate in any plant due to their compact design and operation from one side.
In addition to the compact, closed 100% contamination-protected separation systems, the GEA kytero® centrifuges have a non-contact drive system, which ensures safe operation — even with a high biocontainment.
Assisting the production of vaccines and mAbs
With the annual production biopharmaceutical peptides amounting to more than 17m L, there is clearly a significant market need for the efficient and optimal production of therapies such as monoclonal antibodies (mAbs).
The novel kytero single-use perfusion separators can support the biopharmaceutical industry with this, as its robust and easily scalable upstream processes, are designed for high-intensity, continuous cell separation.
First single-use disc centrifuge for perfusion
Cultivating cells, as well as the subsequent extraction of the desired protein, is the most important upstream process in biopharma production.
In a continuous perfusion process, fresh culture medium is added whilst clarified fermentation both is removed.
With GEA’s kytero, single use perfusion separators enable continuous operation during the perfusion period, allowing the fermentation broth to be continuously clarified.
The concentrated biomass is then returned to the fermenter, ensuring high vitality and productivity.
Continuous means cost-efficient
Utilising continuous processing expedites production time, as operators will no longer have to wait for the end of a batch run to extract target proteins from the medium.
Instead of discarding the cells, they are returned to the bioreactor, meaning production can run for weeks.
This means getting products to market faster, as well as the reusing of cultured cells so no re-culturing is necessary.
Single-use convenience
In the GEA kytero series, the company’s disc technology has been implemented in particularly compact machines with an easy-to-handle single-use separation unit that contains the entire disc pack.
This separating unit and all associated feed and discharge lines - i.e. parts that come into contact with the product - are replaced in one go after a production run, thus offering maximum convenience and protection against contamination.
Gamma-treated exchangeable cartridges are available as an option.