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21 Oct 2020

The future of bacterial manufacturing is now

By Duncan Emerton, PhD; Director, Custom Intelligence, Informa Pharma Intelligence

The level of regulatory requirements biologics are being subjected to is rising and there is an expectation that in a near future there may be “zero tolerance” towards antibiotic-based selection and production systems.

This will create a considerable impact in the field of protein manufacturing using bacterial systems (e.g. Escherichia coli), meaning that pharmaceutical companies need to start making plans for how they expect to tackle this issue within their own organization - and begin now.

Despite significant challenges arising through new regulatory environments, new opportunities to tackle these hurdles will also be created. One such opportunity presents itself in the form of an original genetic selection technology that uses bacteriocins, recently developed by a synthetic biology start-up, which is looking for partners to license its technology to.

Using bacteriocins allows for antibiotic-free selection of expressing clones, which helps to reduce the spread of antibiotic resistant microbes. Bacteriocins have many unique qualities which make them attractive alternatives to antibiotics in production processes. They are ribosomally-synthesized peptides secreted by bacteria and are needed in lesser quantities to kill bacteria than antibiotics, are less likely to cause microbial resistance, while their small size limits the metabolic strain on the host.

From a manufacturing perspective, this novel selection technology has several advantages: it allows for antibiotic-free selection (i.e. avoids using antimicrobial resistance genes), increases the yield and provides better genetic stability. The technology is also easy to use and is 100% plasmid based. It will also be fully compliant with regulatory guidance from governing bodies such as the FDA and EMA where pressure to avoid antibiotic selection is only set to increase.

To get ahead of the curve for your own organization and to find out more about this opportunity, please get in contact with Duncan Emerton, PhD; Director, Custom Intelligence at: [email protected]

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