Pharma Almanac has published an article called "The smart approach to preclinical development for bacterially expressed Biologics" in which Trond Erik Vee Aune, Head of Vectron Biosolutions, shares his experience and learnings from over a decade of working with drug-development companies.
Here are the key takeaways from the interview:
- Working with the right CDMO increases the speed and decreases the cost of bringing clinically approved and commercially viable products to market.
- Bacterial production systems have a lot to offer in terms of efficiency, development and manufacturing costs and susceptibility to host engineering.
- The importance of optimizing the manufacturing process, including the expression vectors, to each protein and how Vectron Biosolutions does it.
The benefits of working with THE RIGHT CDMO to bring clinically approved and commercially viable products to market
Although the objective is, of course, to bring the new product to the market as quickly as possible and as cheaply as possible, taking shortcuts along the way can severely hinder the likelihood of actually reaching a clinically-approved and commercially-viable product. The same logic applies when the production process is not thoroughly thought-through from the beginning, even if it can seem secondary to the inexperienced eyes compared to the clinical validation of the molecule itself. This can be difficult to assess for drug developers as many parameters come into play and must be adapted and optimized for each new molecule. For this reason, it is a good idea to involve a CDMO with the expertise required to establish an optimized, robust and scalable production process, preferably in the early stages of development when several equivalent drug candidates have been identified.
Why Vectron chooses to specialize in bacterial production systems
The first step to developing a recombinant protein production process is determining the production system: mammalian, insect, yeast, algae, bacterial or cell-free. Each has its advantages and drawbacks. And that is why the selection will be based on the unique specificities of the compound to be produced. However, at Vectron we specialize in bacterial production systems because they have a lot to offer in terms of efficiency, development and manufacturing costs and susceptibility to new and advanced host engineering.
The main advantage of working with bacterial production systems
Another advantage of bacterial production systems, especially true when it comes to production in Escherichia coli, is that they are relatively well known and therefore, more tools and methods are available to boost titers and product quality. A non-exhaustive list of adaptable parameters includes:
- Selection of production strain
- Vector system with suitable promoter/induction system
- Codon optimization
- Stabilizing and solubilizing tags
- Chaperone co-expression
- Additional fusion partner
- Growth media
- Fermentation process
The multitude of parameters and possible combinations can quickly become overwhelming for non-specialists. This is why expert CDMOs, like Vectron, are crucial to a smooth transition from pre-clinical to clinical development.
Unique approach to optimizing the production of each protein
Vectron Biosolutions offers more than classic bacterial protein production CDMOs. We guarantee the development of a system uniquely optimized for each and every protein. Unlike most protein production companies, we do not base our development on a previously successful recombinant protein production strategies only. Our toolbox of expression elements, enable the theoretical creation of over 5 million potential vector variants. And allow us the application of an iterative, evolutionary method, to tailor our expression vectors to each product and eventual production constraints brought by our customers. These technologies, which we refer to as VB Expression and VB Evolution, have made it possible for us to design processes frequently yielding protein titers of more than 10 g/L and up to 60 g/L.
Read the full interview
To learn more about:
- The production of biologics in the context of pre-clinical development
- How specialized CDMOs can truly be essential to successful clinical development and commercialization,