What’s New in Downstream Technologies

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As the biomanufacturing landscape continues to advance, downstream technologies are evolving to meet users’ needs. The following products have been developed to support the bioprocessing industry.

Fluid chromatography system

Nexera UC Prep from Shimadzu and the Enabling Technologies Consortium (ETC) is a preparative supercritical fluid chromatography system (SFC) that provides semi-prep purification for the pharmaceutical industry (1). Built on the Nexera ultra high-performance liquid chromatograph platform, the system can be adjusted for user specifications to perform various purification functions including chiral or achiral purifications, single injections, stacked injections, and fraction collections from microliters to liters.

The system comes equipped with a combination injector/fraction collector, a carbon dioxide pump with a compact integrated chiller, a novel gas-liquid separator design for high recovery and low carryover, and preparative software for streamlining operations. Additionally, the SFC shortens purification run time and dry down time while eliminating the need for the solvents used in typical phase prep LC.

“The Nexera UC Prep system is an improved purification instrumentation that meets the specifications and requirements from SFC users across the pharmaceutical industry,” said Mirlinda Biba, PhD, principal scientist, Merck & Co. Inc., and ETC lead for this project, in a press release. “This new generation system provides improved hardware and software features that answer the pharmaceutical industry’s demand for an efficient and robust prep SFC system.”

Updated sensing and control unit for hygienic valves

Alfa Laval introduced an updated version of its second-generation valve sensing and control units for hygienic valves, the Alfa Laval ThinkTop V50 and V70 (2). The new addition, the Alfa Laval ThinkTop IO-Link, is a communication protocol for point-to-point communication between hygienic valves and automation systems via real-time data exchange, improved diagnostics, and simplified configurability and control.

Like the V50 and V70, the IO-Link is equipped with butterfly, single-seat, double-seat, and special valves to meet all valve requirements. Additionally, the new device includes M12 connectors and automatic recording of the hygienic valve stroke duration for faster installation time, the ability to assign priority to critical data, parameters that can be changed from a remote automation system, and data storage, availability, and analytics help for improved operations.

“Suddenly it’s easier to capture, store, analyze, and act upon meaningful data,” said René Stietz, product management Valves & Automation, Hygienic Fluid Handling, Alfa Laval, in the press release. “You get all the finesse of the newly reengineered Alfa Laval ThinkTop-and valuable benefits like more data, higher productivity, and higher yields.”

Compact valve platform

ITT unveiled a new addition to its EnviZion valve product line, the BioviZion, a fractional size valve for 0.25–0.5 in. applications that includes a mechanical thermal compensation system, a quick-change bonnet, and stainless-steel and patented diaphragm studs (3).

The platform features a 360° active seal protection for a leak-free operation that removes the risk of contamination and the need to re-torque after thermal cycling. It also provides less downtime, lengthier preventative maintenance cycles, and a larger production capacity for manufacturers.

“The unique EnviZion design has set a new standard for valves in the BioPharm industry,”  said Dave Loula, global product director for ITT Engineered Valves, in a press release. “We have incorporated the same patented technology into a fractional size valve and added new features to overcome challenges related to dimensional limitations. This provides manufacturers with improved performance and reliability for critical sampling and low flow installations.”

Chromatography column for membrane purification

The CIMmultus EV monolithic column from BIA Separations is a pre-packed chromatography column that works to eliminate non-exosomal vesicles and concentrate exosomes in a low shear atmosphere (4).

The column comes with sizable flow-through channels that are formulated to work with large proteins, viruses, virus-like particles, and pDNA as single-use disposable or multi-use columns (5). Additionally, the column is made of epoxy thermoset materials and carbon fibers, which gives it the similar strength and structure of stainless steel.

“Exosomes represent the next-generation delivery strategy for nucleic acids and other therapeutics, as well as being evaluated as a platform for regenerative medicine with high hopes of bringing more therapeutic options to chronically ill patients,” said Aleš Štrancar, CEO at BIA Separations, in a press release. “We are all looking forward to seeing the impact of our tools on this novel therapy space.”

Protein A Affinity Chromatography Resin

Avantor introduced the J.T.Baker Bakerbond PROchievA, a new Protein A affinity chromatography resin for the purification of antibodies during monoclonal antibody (mAb) production. The resin is used during the Protein A affinity chromatography step of mAbs manufacturing. It also works in conjunction with current manufacturing standards to guarantee stability in workflow processes and compliance protocols (6).

“Biopharmaceutical developers and manufacturers are urgently seeking new tools to drive more efficiency in their production processes. But they cannot compromise on quality standards as they work to provide powerful medicines to patients in a timely, safe, and efficient manner,” said Dr. Ger Brophy, executive vice-president for Biopharma Production at Avantor, in a company press release. “Our resin provides customers with a best-in-class, high-performing alternative to existing purification technology, with the benefit of greater supply chain flexibility and security.”

References

1. Shimadzu, “Shimadzu’s New Nexera Preparative Supercritical Fluid Chromatography System Meets SFC Purification Needs for the Pharmaceutical Industry,” Press Release, Sept. 30, 2019.
2. Alfa Laval, “Alfa Laval ThinkTop IO-Link Boosts Real-Time Data Exchange And Valve Performance,” Press Release, Jan. 27, 2020.
3. ITT, “ITT Engineered Valves Introduces Ultra-Compact EnviZion Valve Product Line for BioPharm Industry,” Press Release, Nov. 18, 2019.
4. BIA Separations, “BIA Separations Introduces CORNERSTONE Exosome Process Development Solution to Enable Industrial Scale Manufacture of Therapeutic Exosomes,” Press Release, Oct. 10, 2019.
5. BIA Separations, “Products for Preparative Applications,” www.biaseparations.com, Feb. 21, 2020.
6. Avantor, “Avantor Launches New Protein A Chromatography Resin – PROchievA – that Provides Supply Chain Flexibility and Improves Downstream Purification Performance for Monoclonal Antibodies (mAbs) Production,” Press Release, March 18, 2020.

Article Details

BioPharm International
Vol. 33, No. 4
April 2020
Pages: 18-20

Citation

When referring to this article, please cite it as L. Lavelle, “What’s New in Downstream Technologies,” BioPharm International 33 (4) 2020.