Process Development
Process development is of fundamental importance for bioproduction. It translates scientific knowledge into standardized processes and ensures that biotherapeutics are manufactured according to the highest standards of quality, safety and efficiency.
The fermentation process is one of the major cost drivers in industrial protein production. Our process development experts create robust and reproducible processes. We combine scientific knowledge with expertise to increase microbial strain productivity.
The fermentation processes developed at ARTES are based on low-cost, fully synthetic media avoiding expensive additives (e.g. methanol or IPTG) and aiming at short production times.
Our facilities with state-of-the-art equipment, combined with the expertise of our team, enable us to efficiently take your recombinant protein from concept to industrial-scale production.
High productivity achieved with ARTES´ technologies translates directly into savings in energy, investment, consumables and waste.
Upstream and downstream process development
Upstream and downstream process development at ARTES Biotechnology is designed from the outset to meet cGMP and large-scale requirements for subsequent routine manufacturing. Special emphasis is placed on reproducibility and cost reduction. In-process control and final characterization of the product and host/process related impurities are included in our process development. Where applicable, this characterization is performed in accordance with international pharmacopoeia.
ARTES provides all the necessary documentation to transfer the process to your manufacturing site or to a CMO. In addition, we offer product samples and arms-length assistance in the transfer of the developed process.
ARTES can provide contracted services for developing cGMP-compliant methods, routine analyses, and large-scale manufacturing (both nonGMP and cGMP) in close cooperation with our industrial partners.
Our offer includes:
- upstream process development
- downstream process development
- in-process and quality control assay development
Process optimization
We can assist you in optimizing your current process, whether you need to improve a single step or the entire process. Our services range from troubleshooting individual operations to optimizing the entire process.