TAVALISSE™ is a twice-daily regimen indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to a previous treatment.
ARTES Biotechnology, a profitable German biotech company, offers innovative solutions in recombinant protein production and process development. We provide our technology and know-how for the establishment of reliable and competitive processes used for the production of biosimilars and for new pharma-protein targets as well as for enzymes applied in fine chemical or life science industries.
The focus of our service and licence offer is on gene expression in the high-yield yeast system Hansenula polymorpha (methylotrophic alternative to Pichia). This platform technology is secured by our own IP and by exclusive licences worldwide.
Biopharmaceutical expression yields
The Hansenula technology platform has gained worldwide attention due to its superior expression yields, proven by a number of registered pharma products and successful pre-clinical and clinical studies (e.g. hepatitis B vaccine, hepatitis C vaccine, insulin, interferon alpha2a and 2b, hirudin, elafin, flu vaccines). Due to the absence of endotoxins and allergens, such as allergenic sugars, Hansenula is accepted as a safe production organism for high-value pharmaceutical products.
ARTES’ technology excels with safe, fast and efficient production features. Competitive advantages over other microbial systems translate into reduced cost of goods. In the case of interferon alpha2a our Hansenula-related process decreases the production costs down to approximately 25% compared with a common E. coli process.
Strain, upstream and downstream processes and products
Strain, upstream and downstream process, QC:
- Interferon a2a
- Interferon a2b
Strain, upstream process:
- hGrowth hormone
ARTES offers transfer of process technology for the local production of recombinant APIs. This transfer includes the production strain and process documentation and may be extended by training batches, bulk supply and formulation development.
Feasibility studies and process development for the generation of recombinant protein strains
ARTES offers tailor-made feasibility studies for the generation of recombinant strains to provide the most efficient solution for the customer’s protein production. A team with up to 20 years’ experience in contract research, troubleshooting of expression problems, process development and production of biopharma targets focuses on your individual project.
There is a proven track record in this area of contract R&D achieved with a broad proprietary platform of tools and technologies. ARTES has the ideal combination of efficient expression elements and secretion signals, specially engineered host strains and short, inexpensive fermentation strategies that allow for high-yield, economically feasible protein production. Our deliverables include characterised production strains and a professional documentation suitable for further registration purposes.
Enhanced protein secretion
The exclusive Chaperone technology enables ARTES to optimise secretion in Hansenula and also in every kind of yeast. The toolbox is successfully applied for debottlenecking of secretion and it is applicable for strains that are newly produced or already inserted in a process. It is a tool particularly suitable for troubleshooting and for reduction of production costs.
The co-expression of host-derived chaperones has been established for the reliable and significant boost of secretion levels of recombinant products. Between 50% and 350% increase in the secretory capacity of our host strains have been achieved for several different target proteins.
Process development and quality control for recombinant proteins
Following the successful supply of production strains, ARTES Biotechnology can act as general contractor for all further steps of product development. For this ARTES offers lab-scaled fermentations (up to 1l) and can support with downstream processing know-how. Furthermore can we ensure, via a network of partners, up-scaling service and cGMP manufacturing at scales up to 1,000l.
Global technology licensing – service and licence from one source
ARTES Biotechnology offers internationally protected systems, technologies and products, as well as unpatented know-how and expertise. All relevant licence rights required for commercialisation of the client’s product can be obtained from only one source. Terms and conditions are flexibly adapted to the business case and linked tightly to commercial success.
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