On October 1 Thermo Fisher Scientific (TFS) introduced the Thermo Scientific HyPeak chromatography system, the first single-use chromatography system for bioprocessing offered by the company, with key applications in therapeutic protein and vaccine development.
Single-use chromatography at process scales has seen limited adoption due to economics and scale. With flows ranging from one liter/hr to 1980 liters/hr, the new system achieves scalability from development through manufacturing, through a novel combination of pumps and fluid transfer assemblies. Other features include zero dead-leg and a ring flush valve manifold. According to TFS, HyPeak reduces buffer consumption during downstream operations, thereby improving product yield, and operates under the Emerson DeltaV automation infrastructure for ease of integration and tech transfer.
“This flexibility to scale can potentially reduce the number of required skids in the facility, depending on process requirements and the chosen configuration,” says Babu Sivaraman, director for product management. “Other solutions use pinch valves that do not allow scaleup by more than two tube diameters. “The valve manifold also provides easy fluid transfer assembly insertion, helping to ensure safe operation while providing a quicker turnaround time.”.
Resin costs, more than any other factor, are the reason process chromatography remains the bugaboo of single-use bioprocessing. Protein A resins, which are essential for monoclonal antibody platform processes, cost upwards of $1 million for a single 1-meter diameter column. Other common resins cost about half as much. Developers are therefore reluctant to design processes that simply throw these materials away after a single use. One work-around involves regenerating resins after a run for limited re-use—“single-campaign” vs. actual single-use. The other option of course is continuous chromatography, which requires revamping or re-designing the entire downstream purification train.
HyPeak does not lower the cost of resins, but it does take full advantage of this precious resource. “Resin use is not unique to single-use systems,” Sivaraman says. “But HyPeak is column-agnostic: the end user can use self-packed or pre-packed columns—resin or membrane—suited to their process, within our system specifications”
HyPeak system hardware is built as a modular system, with all the features required to run a purification in the base configuration and options for advanced or custom configurations. When operating in batch mode, batch data are retained by the batch reporting system and reports can be generated and issued using InfoBatch, a reporting module included with HyPeak.