Unmatched scalability, process control and crude
purity of large-scale oligonucleotide synthesis
OligoNavigator Pro is a fully automated large-scale oligonucleotide synthesizer and covers a range from 10 mmol up to 5 mol per batch. Each design is customized depending on the customers specifications and is based on verified components from well known suppliers in the industry.
The broad scale covered by the OligoNavigator Pro instrument enables production of hundreds of kilos and/or tons of oligonucleotides every year.
A new generation of large-scale oligonucleotide manufacturing
OligoNavigator Pro is a fully automated solid-phase oligonucleotide synthesis instrument using flowthrough column technology. It is a compact, pump-driven instrument for large-scale synthesis in the scales 10 mmol - 5 mol, and supports production of both GMP and non-GMP grade oligonucleotides. The synthesis method is first developed and optimized on an OligoNavigator or OligoNavigator Plus instrument before transferring and manufacturing on an OligoNavigator Pro instrument. The PeptiSoft synthesis management software is used for all instruments.
The instrument is built using industrial-grade components from well-known suppliers in the industry. It has been designed for the commercial manufacturing of oligonucleotides and to be able to meet the needs of various synthesis chemistries. Some key characteristics of the system are:
State-of-the-art flexibility of individual cycles in synthesis methods, backbone chemistry, use of custom-made monomers, including monomers ready for bioconjugation.
Cost-efficient and high-quality synthesis with high purity, yield, and reproducibility.
Two-column positions for sequential, non-stop synthesis and up to 12 amidite monomer inlets.
Easy scale-up due to linear flow rates and washing using column volumes.
Real-time monitoring with conductivity and diode-array detectors (including the UV/VIS spectrum).
A heater for synthesis at elevated temperatures and temperature control.
Works with PeptiSoft synthesis management software which is designed according to 21 CFR Part 11 and GAMP5.
Installation and Operational Qualification (IQ/OQ) documentation is available.
Extremely accurate pump system that adds the correct amount of liquid to the system (error is only +-0.05%).
Key new features of the OligoNavigator Pro
The software is built from scratch for GMP synthesis of oligonucleotides with process development and scalability in mind. We have developed a synthesis matrix that makes it easy to set individual parameters of any synthesis step in any synthesis cycle. This allows for improved synthesis control. The software is also much easier to operate than others on the market and brings a modern, user-friendly interface to the field of oligonucleotide synthesis.
A built in heater and cooler allows for heating up to 50°C or cooling down to 10°C in any individual synthesis step. Performing synthesis steps at elevated or lower temperatures can be of strong interest to increase the speed of various steps of a cycle such as the activation or coupling step. It also makes it possible to control the temperature of the entire cycle to keep it constant.
Higher purities and yields have been achieved than for industry standard synthesis instruments.
Addition of new in-line monitoring features such as oxidation, conductivity, complete-UV scans and Near Infrared NIR (process-scale only) leads to improved monitoring, automation and synthesis control. PeptiSystems is currently working on further monitoring improvements where the software itself will be able to determine when any step in the synthesis cycle is complete and automatically move on to the next step, without any manual estimations from the operator.
Easier scale-up and transfer of optimized synthesis method. The same software is used during large-scale synthesis as in pilot-scale synthesis.
Extremely accurate addition of liquids by the pumps with an error rate of +-0.05%. Adding the exact correct amount of liquid saves on amidite and solvent costs significantly. It also improves synthesis control.
Specifications for OligoNavigator Pro
Whitepapers, brochures and other related documents will soon be made available for download here.