What’s New in Manufacturing: Downstream Technologies

November 1, 2019

BioPharm International

Volume 32, Issue 11

The latest advances in downstream technologies include stainless-steel liquid chromatography columns, sensing and control units for hygienic valves, a wettable phase for separation and purification, a buffer delivery platform, and a new filter integrity tester.

Advancements in downstream technologies are imperative to improving the reliability and capacity of biomanufacturing. The following products promise to aid the bioprocessing industry.

Stainless steel liquid chromatography column

DAC Ergo by Asahi Kasei Bioprocess (AKB) is a liquid chromatography (LC) column that allows stainless-steel dynamic axial compression LC columns to be unpacked, disassembled, and reassembled by a single operator using a hydraulic system in collaboration with a bottom plate-fastening approach (1).

Unlike smaller particle chromatography devices, which are unpacked manually by removing the bottom plate from the depressurized column, the new device uses a quick-release bottom plate-fastening design and a hydraulic column lift driven by a handheld control pendant. The plate is then fastened to the bottom of the column tube using I-bars instead of traditional threaded bolts and, once the column is correctly positioned, the bars can be disengaged by hand without tools.

 “DAC Ergo allows a single operator to disassemble the column bottom plate and unpack the column in less than 30 minutes, while the performance of the column and its flow distribution remain first-rate,” said Chris Nordhoff, president of AKB America and head of AKB’s Fluid Management business unit, in a press release. “Through both operator safety and labor savings perspectives, this new feature aligns strongly with our division slogan of ‘Pioneering Biologics Safety and Manufacturing Efficiency’.”

The columns are available in diameters between 60 cm and 120 cm with pressure ratings up to 35 bar.

Updated sensing and control unit for hygienic valves

Alfa Laval introduced an updated version of its valve sensing and control unit for hygienic valves, the Alfa Laval ThinkTop. The new additions, the Alfa Laval ThinkTop V50 and V70, are the second generation of the device and now include the latest advances in technology, according to the company (2).

The new devices are chosen based on the number of solenoid valves required and can cover all valve requirements. The V50 comes equipped with butterfly, single-seat, and double-seal valves, while the V70 comes with the same features as the V50 plus a double-seat and special valves.

The redesigned valve sensing and control units also include a 360° LED visual status indication, a repositioned Gore Vent, an auto-setup feature for simplified commissioning, a compact industrial exterior suitable for tight installations, burst seat cleaning, and a QR code for access to support materials and direct support.

“We have listened carefully to what customers want from a valve sensing and control unit,” said René Stietz, Product Management Valves & Automation, Hygienic Fluid Handling, Alfa Laval, in a press release. “The changes we’ve made to the ThinkTop are highly responsive to customer needs and therefore highly relevant-for instance, faster and more intuitive setup without compromising durability and reliability.”

Wettable phase for separation and purification

Kromasil unveiled a new wettable phase engineered for the separation and purification of biomolecules, impurity removal, and API manufacturing under aqueous conditions. The phase works in conjunction with the Kromasil 100 Å C18(w), which permits selectivity and resolution opportunities to isolate impurities and cultivate samples with amino acids and peptides (3).

The phase is end-capped and allows for sample loading and a 100% aqueous run start. Along with this, the Kromasil 100 Å C18(w) comes with 10 µm particles as bulk and packed columns from 4.6 mm to 21.2 mm inner diameter.

Buffer delivery platform

The BioContinuum Buffer Delivery Platform from Millipore Sigma is a new element in the BioContinuum Platform for next-generation bioprocessing, which includes the company’s “contiGuous” bioprocessing (4).

The delivery platform is comprised of a selection of distinct buffer concentrates, Mobius Select single-use assemblies, and an automated buffer dilution system with tailored system services. It also produces process buffers with less resources and facility space, which provides a streamlined buffer suite and an easier manufacturing process.

Using the contiGuous processing element, the platform will handle the materials, production, testing, and analytics elements of the processing techniques.

“MilliporeSigma’s vision goes beyond continuous manufacturing and will deliver contiGuous bioprocessing-a seamless confluence of digital and intensified bioprocessing building blocks,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma, in a press release. “Our BioContinuum Buffer Delivery Platform is a perfect example of the high degree of connectivity that contiGuous biomanufacturing can achieve.”

New filter Integrity Tester

Sartorius Stedim Biotech announced the launch of the new Sartocheck 5 Plus to its current line of Sartocheck integrity testers (5). The new device improves the detectability of operator errors, improper test set-ups, and out-of-tolerance environmental conditions. Advanced functions ensure data integrity and compliance with future requirements of quality risk management, such as the upcoming Annex 1 of the European Medicines Agency.

Compared to other filter testers with limited flow measurement capabilities, the Sartocheck 5 Plus covers a range of integrity testing from small syringe filters up to large, multi-round housings and crossflow cassettes, with diffusion rates of up to thousands of milliliters per minute. An automatic test-time feature for diffusion and water intrusion, along with accelerated bubble point testing, reduces overall test time, and parallel bubble-point testing enables up to 10 small filters to be checked with one filter tester. A 12-inch screen has an ergonomic interface, easy-to-clean design, and inherent virus protection.

References

1. Asahi Kasei Bioprocess, “Asahi Kasei Bioprocess Launches DAC Ergo, an Innovative Large-Scale Chromatography Column Design,” Press Release, July 24, 2019.
2. Alfa Laval, “Introducing Alfa Laval ThinkTop V50 and V70,” Press Release, June 20, 2019.
3. Kromasil, “The New Kromasil Wettable Phase,” Press Release, Sept. 2019.
4. MilliporeSigma, “MilliporeSigma Elevates its BioContinuum Platform Strategy to Deliver ‘ContiGuous’ Bioprocessing,” Press Release, April 2, 2019.
5. Sartorius Stedim Biotech, “Sartorius Stedim Biotech Launches New Sartocheck 5 Plus Filter Tester,” Press Release, Oct. 21, 2019. 

Article details

BioPharm International
Vol. 32, No. 11
November 2019
Pages: 48-49

Citation

When referring to this article, please cite it as L. Lavelle, “What’s New in Manufacturing: Downstream Technologies,” BioPharm International 32 (11) 2019.

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