Tosoh Bioscience GmbH, a provider of chromatographic solutions for the separation and purification of biomolecules, has announced the launch of the Octave® BIO Multi-Column Chromatography (MCC) system. This system, combined with the SkillPak™ BIO pre-packed columns, enables customers to quickly and efficiently develop pre-clinical processes.
Octave BIO is the first in a series of MCC instruments targeting all stages of biomolecule manufacturing, from pre-clinical to clinical and GMP manufacturing. The company is expected to launch Octave PRO, a GMP manufacturing scale MCC instrument, by Q3 of 2023. The MCC line of instruments is part of the company’s initiative to improve biomanufacturing productivity and provide much-needed process flexibility while maintaining the highest product quality and reducing the overall cost of production.
Octave BIO multi-column chromatography systems
Specifically designed for the intensification of biomolecule purification processes, the Octave BIO is a comprehensive multi-column chromatography system for process development and proof of concept. The unique modular design can accommodate a wide range of requirements and unlocks the resin savings, buffer savings, and other tangible benefits that MCC can provide. Consistent with the typical bioprocess application of MCC, this versatile system can accommodate various processes, such as continuous AFC capturing, gradient polishing, and intensified batch chromatography.
The system flow path features PEEK tubing and a unique proprietary biocompatible valve block design that allows for the connection of 1 to 8 columns to accommodate increasingly intensified upstream titers while reducing the clutter of rotary valves and external tubing. The system also features six independently driven pumps each of which are user replaceable among four sizes to cover a wide range of process scales. Built-in UV, conductivity, and pH detectors enable complete process monitoring, while added features like the onboard sample injector, mixer, and gradient capability enable process design experiments. Included BIOController™ and ProComposer™ 21 CFR Part 11-compliant software tools provide an easy-to-use interface to understand and implement multi-column chromatography, in addition to the Method Wizard, which facilitates the conversion of conventional batch methods to MCC processes.
SkillPak BIO pre-packed columns for MCC applications
SkillPak BIO pre-packed columns have been designed to unlock the best performances in combination with Tosoh Bioscience’s best-in-class TOYOPEARL® resins. Using proprietary column hardware and packing technology along with unique MCC-specific dimensions, SkillPak BIO columns can significantly extend the boundary of MCC productivity. Operating at significantly lower pressures compared to their batch counterparts, SkillPak BIO columns will significantly improve MCC instrument productivity by allowing higher system flow rates.
Octave PRO and SkillPak PRO for large-scale production in regulated environment
The company plans to introduce Octave PRO in 2023, a GMP-compliant MCC skid with up to 2.5 L/min flow rate targeting clinical processes. Octave PRO will be launched with a fully single-use flow path and PLC control system designed to meet the highest standards of GMP manufacturing requirements. Additionally, the operating software will provide a seamless transfer of MCC purification methods from Octave BIO in process development settings to Octave PRO in GMP manufacturing suites, further simplifying the scale-up process. At launch, Octave PRO MCC instruments will be accompanied by a variety of larger SkillPak PRO, GMP-ready pre-packed columns with MCC-optimized dimensions.