A major challenge in downstream purification of mAbs is the formation and removal of aggregates. CHT XT is the newest addition to the CHT family. This study shows that CHT XT is capable of minimizing the aggregate content during mAb purification. It can also reduce other product- and process-related impurities to significantly low levels. These data demonstrate that CHT XT is an exceptional tool for polish purification of monoclonal antibodies.
Compare two purification strategies and their effectiveness to offer high product yields and clearance of acidic impurities from the expression host cells.
Protein A affinity purification has multiple limitations in terms of productivity at manufacturing scale and the costs associated with making commercial antibodies, especially biosimilars. There could be a viable alternative, an ion exchange (IEX) resin, Nuvia S, for the capture purification of such biomolecules. Read instances where its use has resulted in a productive and economical purification workflow.
Biosimilar purification costs constitute more than half of the total development costs. A significant number of these costs are due to the expense of Protein A–based media. This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.
The large size of IgMs makes their purification very challenging. See how Bio-Rad's new strong anion exchange resin (AEX), Nuvia HP-Q, has the ability to overcome the multiple issues faced when purifying large biomolecules.
Once you have successfully encapsulated an (API), the next task is to characterize that product and understand its release kinetics, such that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.
Hear how an adaptive and evolving platform of proven and novel technologies enables biomanufacturers to successfully accomplish their bioprocessing goals through either intensified, connected or continuous bioprocessing.
As the industry is looking to increase speed to market, reduce manufacturing resources and increase product safety, there has been a push to implement single-use technologies. Combining both SPTFF and single-use technology can be a powerful tool for the efficient manufacture of biologics.
Where sterility will be claimed, regulatory agencies worldwide require that the integrity of sterilizing-grade filter(s) is verified before and after use to ensure filter performance. This webinar highlights best practices and key considerations for performing filter integrity tests to give you a better understanding of how to design a robust integrity test operation in your own facility.
Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar a M-pleat pattern is demonstrated to provide up to 100% more membrane area than a conventional pleat pattern.
Are you purifying large biomolecules such as IgMs and viruses, but unable to get good purification efficiency and productivity with you ion exchange (IEX) resins? Read how Bio-Rad's Nuvia HP-Q Resin - a strong anion exchainge resin - helps achieve high purification productivity and facilitates the HTP purification demanded by current processes.
At Singota Solutions, robotic aseptic filling is done in a completely gloveless workcell, providing clients highly repeatable precision fills with reduced particulate counts versus conventional technology. Our system is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota’s state-of-the-art manufacturing facility is equipped to handle a wide range of small molecule and biological formulations including potent compounds.
At Singota Solutions, robotic aseptic filling is done in a completely gloveless workcell, providing clients highly repeatable precision fills with reduced particulate counts versus conventional technology. Our system is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota’s state-of-the-art manufacturing facility is equipped to handle a wide range of small molecule and biological formulations including potent compounds.
