Levitronix® has released the first ultrasonic, single-use (SU) flowmeter on the market. Characterized by high accuracy and superior performance, LEVIFLOW® SU noninvasive flowmeters enable a highly precise and low-cost flow measurement. With an accuracy of <1% of reading and flow ranges from 1 mL/min to 80 L/min, they offer the highest level of accuracy for measuring liquids in biopharmaceutical and other applications that require FDA, USP-VI, BSE/TSE, and animal-component–free materials that can be gamma sterilized. Technical Background: Figure 1 illustrates the…

The new LEWA EcoPrime® LPLC chromatography and enhanced buffer dilution platform combines proprietary fluid design and the LEWA Intellidrive® pump technology to deliver unrivaled reproducibility and accuracy. The integrated buffer in-line dilution (BID) option prepares point-of-use buffers combining two unit operations into a single, space-saving skid. A single LEWA EcoPrime system has the flow range of up to two conventional LPLC units while delivering gradient accuracy of greater than ±1%. Because of its dynamic range, EcoPrime LPLC can bridge the gap…

Bioprocess intensification leads to more efficient, flexible, and cost-effective biopharmaceutical manufacturing facilities. Single-use systems designed for continuous operation facilitate process intensification. Pall Life Science’s Cadence™ BioSMB PD platform is the first disposable flow path, continuous multicolumn chromatography solution that is fully scalable from a process development laboratory to good manufacturing practice (GMP) manufacturing. It provides an economically viable, disposable chromatographic solution for even the most demanding and costly chromatographic steps. During multicolumn countercurrent (also known as simulated moving bed, or…

In June 2016, Parker domnick hunter began manufacturing in its new single-use facility in Birtley, Co Durham, UK. Here I discuss the approach taken in the design, testing, and manufacturing of single-use assemblies and some of the advantages they can have in terms of lead times, inventory control, and supply chain robustness. Challenges of Customization For some time, the message relayed to biopharmaceutical manufacturers was to design exactly what you want and need for each process. That meant a customized…

TOYOPEARL AF-rProtein A HC-650F and two other commercially available protein A resins (one of them also a “high capacity” resin) were compared on a cost-per-gram of monoclonal antibody (mAb) produced basis at multiple resin prices from $7,000 to $17,000 per liter as well as three different column configurations. For in-depth comparison, the median resin price of $12,000 per liter was used as a basis to determine comparative production costs among the three resins tested. The configuration used to model what…

Various unit operations are needed in downstream processing (DSP) of biologics to remove process‑related impurities such as host‑cell proteins, nucleic acids, viruses, and endotoxins. This application note describes the potential of a salt‑tolerant anion‑exchange resin to achieve outstanding clearance of endotoxins and viruses. Introduction Endotoxins are lipopolysaccharides (LPS) originating from cell membranes of Gram‑negative bacteria. They are frequent contaminants of recombinant proteins produced in microbial expression systems. On the other hand, expression of more complex proteins in eukaryotic systems carries…