When it comes to biopharmaceuticals, the process is the product – which is why we offer a development process based on incisive analytics that enable reliable, scalable cGMP production.
A stable, robust and consistent process is critical to your production process.
It’s especially important for biopharmaceuticals with very complex molecular structures.
Whenever changes are made to a given strain, fermentation or recovery process this can potentially alter product-related impurities, host cell proteins, nucleic acids, and other contaminants. From here, extensive analytical and clinical studies may then be needed to demonstrate equivalence of the product produced with the new process – all of which adds time, costs and risks to the project.
This is why we invest heavily in intelligent analytics and upfront planning in all process development.
The process is the product
Sometimes uncertainty is unavoidable. For example, when it comes to scaling up fermentation processes the most widely used catalogue strains are not compatible with large-scale fermentation, making performance uncertain with no guarantees.
At DSM we remove this major barrier by offering ready-to-use technology platforms that enable predictable and straightforward scale-up; minimizing the work needed to demonstrate equivalence of a product with the scaled-up process.
These technologies include standardized expression platforms, with ready-to-use, robust and scalable fermentation and recovery processes; as well as a state-of-the-art analytical toolbox, including high-throughput screening technology, for fast and reproducible results.
How can we help?
Our expertise in cell line development, biopharma process development, product formulation, and supporting analytics is state of the art. It includes:
- Molecular biology
- High-throughput classical strain improvement
- Metabolic pathway engineering
- Cell banking
- Protein engineering
- High cell-density fermentation
- Fermentation medium development
- Microbiology and hygienic design
- Product recovery and isolation
- Chromatographic purification
- Membrane filtration
- Biocatalysis and immobilization
- Crystallization and drying
- Product formulation and stabilization
- Analytical assay development.
DSM Biotechnology Center
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