In the manufacture of biopharmaceuticals, single-use technologies are now employed throughout the workflow — from buffer and media preparation to bioreactor cultures for vaccines and biotherapeutics production as well as in the storage of those intermediates and bulk biologics. This diversity of applications adds to the difficulty in establishing appropriate testing and requirement specifications, as well as qualification and validation approaches. The integrity and performance of single-use systems depends primarily on the characteristics of the film, the largest component (and…

Parker domnick hunter’s HarvestClear™ Filtration System is a complete, out-of-the-box filtration system that provides automated clarification of small-scale bioreactor outputs while maximizing filtration performance. The HarvestClear™ System allows for walk-away cell-culture harvest, reducing hands-on time and increasing operator safety without filter blockage. Summary The clarification of batch and fed-batch bioreactor systems can pose a practical challenge to biopharmaceutical manufacturers because of high cell densities in cell culture process streams. The HarvestClear™ Filtration System provides an easy solution for clarifying 1–20…

Background Tryptic soy broth (TSB) is a general-purpose medium used for cultivating numerous microorganisms including Serratia marcescens, a Gram-negative rod commonly found in water and involved in pharmaceutical contaminations (1, 2). This study examines the growth characteristics and bacterial retention of S. marcescens (ATCC #14756) in five types of TSB: EMD TSB (type 1), EMD Irradiated TSB (type 2), EMD Non-Animal Origin TSB (type 3), EMD Non-Animal Origin Irradiated TSB (type 4), and Competitor A TSB (type 5). Materials and…

Eshmuno® CPX resin is a new strong cation exchanger developed using EMD Millipore’s tentacle technology to provide high binding capacity, resolution, and target yield. For process improvement purposes, this resin was applied for capture of rhFGF18, a fibroblast growth factor (expressed in Escherichia coli) in phase 2 clinical development for restoring damaged cartilage surface in osteoarthritis. Early purification work used Resin A at low load (12.3 mg target/mL CV) and moderate flow rate (180 cm/h = 6.7 min residence time,…

A platform approach for MAb purification is desirable as it saves both time and money in process development. GE Healthcare Life Sciences’ MAb toolbox employs protein A chromatography media (resins) as well as a wide range of options for polishing purification steps. One of these options is Capto adhere ImpRes, a cost-effective and flexible multimodal anion exchange chromatography medium designed for high-resolution polishing of MAbs. The medium allows operation in either bind-elute (B/E) or flow-through (FT) modes. Here we describe…

The vaccine manufacturing industry is continuously seeking more flexible and time-saving solutions for a quicker response to pandemic outbreaks (1, 2). For influenza, vaccine is traditionally produced in fertilized hen eggs and purified in fixed steel equipment. Here we describe the scale-up of a downstream purification process of cell-based influenza virus, from a 10 L cell culture to the purification from a 50 L culture using ReadyToProcess single-use technology. Single-use technology reduces the need for time-consuming device preparations, such as…

Table 1:&#8 LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. A customer came to us several years ago requesting a low-pressure liquid chromatography system with a flow range of 20–2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed and…

Figure 1:  Current downstream processing strategies for recombinant proteins often require multiple chromatographic steps, which may lead to poor overall product yields. Product purification can be especially difficult when a target protein displays reduced stability, has isoforms or misprocessed variants, or needs to be purified from a complex mixture containing a high level of impurities. Through highly specific antibody–antigen based interactions, affinity chromatography brings significant technical advantage to these protein purification challenges. Developed to tackle such challenges, CaptureSelect™ technology is…

Protein A chromatography is still the preferred capture step in monoclonal antibody (MAb) production because of its high selectivity and robustness, although cation-exchange (CEX) or multimode chromatography techniques are claimed as alternatives. KANEKA KanCapA increases the value of protein A affinity chromatography for MAb production. Kaneka’s unique combination of a proprietary-designed alkaline stable protein A ligand and a highly cross-linked cellulose base matrix meets customer requirements for improved performance, high binding capacity, alkaline and chemical stability for cleaning in place…

Table 1:&#8 Sartobind® STIC Pico and Sartobind® STIC Nano are the smallest scalable representatives of the Sartobind® STIC membrane adsorber family. STIC is a salt-tolerant anion-exchange membrane effective at removing contaminants in buffers containing up to 200 mM NaCl, saving time and reducing costs by avoiding buffer changes. The small size and high throughput of these capsules make them perfect for use on automated chromatography systems such as the popular ÄKTA® series offered by GE Biosciences. Although both Pico and…