Standardizing equipment in biopharmaceutical production streamlines operations, saving end users time and money. An area ripe for standardization is the use of genderless connections, those in which the connector halves are identical in design. Historically, single-use connections have involved male and female halves, but using two different parts can create several inefficiencies and complications, such as Increased ordering complexity Greater risk of specifying the wrong system or connection, resulting in downtime and last-minute adjustments Longer lead times Increased stocking requirements…

Clarification of fermentation broths is one of the most important steps in bioprocessing. The first purification step after fermentation is the cell harvest, which is designed to remove cells and cell debris as well as to reach maximum product yield in compliance with existing regulatory environments. Standard technologies (centrifugation, separators, membrane, and depth filtration) can no longer handle the high particle loads (>108 cells/mL) in an economical way. Deciding on the right purification system involves addressing questions about process performance,…

Interest in continuous bioprocessing is growing rapidly, and such an approach has shown to have a potential in providing gains in both productivity and savings in cost of goods sold. The ÄKTAâ„¢ pcc 75 chromatography system can be used for purification of target proteins in continuous downstream processes using periodic counter-current chromatography (PCC). PCC enables greater use of chromatography resin capacity, allowing sample loading to much higher levels than what is possible in traditional batch chromatography by using safety factors…

In batch-mode chromatography, operating conditions do not allow full use of the total media capacity (1, 2). Bio-Sequential Chromatography (BioSC®) is an open-loop process for the separation of multicomponent solutions (3). The unique column of the batch mode is replaced by a series of smaller columns (from two to six). This design maximizes the use of the media without product loss along the process sequences. The BioSC® Lab automated system is based on the multicolumn chromatography process, designed and provided…

Cellulose is well known as a natural raw material that has mechanical strength, lower nonspecific adsorption, and good biocompatibility. In addition, cellulose particles have unique pore-size characteristics appropriate for chromatography of biopharmaceuticals. Ion-exchange chromatography (IEX) is an important step for biopharmaceutical manufacturing. Specifically, cation-exchange chromatography (CEX) can be used as a capture step in monoclonal antibody (MAb) purification. Recently, advanced IEX resins have been developed using polymer modification techniques. Initial screening of conditions such as pH and ionic strength is…

Currently more than 70 biosimilar monoclonal antibodies (MAbs) are under development, and multiple originator MAbs are going off patent in the next three to four years. Protein A affinity media material remains the most important workhorse for the purification of monoclonal antibodies. Protein A media has a high impact on both development and manufacturing costs, particularly during early stage clinical phases. This note summarizes key performance parameters for JSR Life Science’s Amsphere A3 high-capacity protein A resin for six biosimilar…