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]
Related News
-
News Women in Pharma: Moving beyond discussions and into best practice at CPHI Milan
In this second CPHI Milan special of our monthly series, we cover the key takeaways from the Diversity & Wellbeing track held on October 10, 2024. -
News AstraZeneca invests in AI collaboration for cancer drug trials
The British-Swedish pharmaceutical giant is partnering with biotechnology firm Immunai Inc to increase the efficiency of some cancer drug trials. -
News Ozempic and Wegovy prices questioned as Novo Nordisk faces US Senate hearing
The CEO of Novo Nordisk was grilled during a US Senate committee hearing on September 24, 2024, in which the exorbitant prices of the Danish company’s blockbuster drugs Ozempic and Wegovy were called into question. -
News The BIOSECURE Act: implications for the pharma supply chain
On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin... -
News On Track at CPHI Milan: Thermo Fisher Scientific Track Sponsor interview
With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma. -
News CPHI Milan Speaker Spotlight: Pharma Manufacturing and Localisation in Africa
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Eli Lilly licenses rheumatoid arthritis manufacturing in Africa
American pharmaceutical company Eli Lilly has signed a partnership with Egyptian organisation Eva Pharma to localise manufacturing of rheumatoid arthritis treatments in Africa.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance