Laureate & Selexis partner to speed production of biologics
Biotechs are under pressure cut development costs and times and the partners believe they can help by streamlining the production of materials for clinical trials by. This is achieved by performing cell line creation and manufacturing process development in parallel.
For instance, a client seeking to use Switzerland-based Selexis’ services to develop high yield mammalian cell lines could also outsource its manufacturing operations to Laureate, with the cooperation between the partners helping to shorten timelines.
Robert Broeze, president & CEO of Laureate, believes this “provides a very compelling value proposition for clients looking to outsource biopharmaceutical manufacturing”.
This belief is underpinned by the strength of the respective offerings. Selexis claims it can produce stable, high yield mammalian cell lines for use in recombinant manufacturing of therapeutic drugs in five weeks.
Furthermore, the process improves the yield and stability of production cell lines, according to Selexis, and can increase recombinant protein expression in mammalian cells in suspension and in serum-free by more than 20-fold.
To achieve this it first generates optimised expression vectors containing Selexis Genetic Elements. The company then applies its high throughput transfection method, combined with a first limiting dilution, to create high producing cell clones.
These cell clones are then analysed for growth rates, specific productivity and product integrity and if necessary a secondary cell cloning from five primary cell lines is performed.
While this process is taking place Laureate can develop current good manufacturing practice (cGMP) compliant production processes at its US Food and Drug Administration (FDA) registered facilities in Princeton, New Jersey, US.
This allows for the therapeutic to be quickly transferred to production.