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There is no question that social media is changing the way we communicate with each other. For professionals, LinkedIn® is one of the most popular platforms today, allowing us to connect with colleagues, share information and stay up-to-date on the latest industry trends and topics. That’s why we are moving this ChromaTALK platform to LinkedIn

Once a target protein has been identified to become a potential drug, the purification process has to yield an even higher quantity of proteins for further studies. While it is critical to maintain the product’s purity and to fulfill all requirements in terms of quality, the purification processes have to be scaled up – usually from the mg-level up to ...

Based on recent advances in biotechnology, the introduction of protein and peptide drugs is growing rapidly. Nearly all applications require a high purity. Thus, efficient chromatographic column separations are necessary. The most important technique is ion exchange chromatography (IEX). This technique results in high purities combined with high recoveries while the operational costs are rather moderate. In addition, for ion ...

Biologicals like monoclonal antibodies carry with them a risk of viral contamination. This risk is generally mitigated through careful screening of source materials and raw materials and monitoring of process intermediates for the presence of viruses. However, it is possible that viruses may enter the process and escape detection. For this, viral clearance during ...

For recombinant protein and monoclonal antibody produced on mammalian cell line like CHO cells, virus inactivation is frequently accomplished through low pH treatment and detergent treatment at low concentration.  Both steps are suitable to inactivate a specific group of virus which are envelope viruses, but are not capable of inactivating the more resistant,  non-envelope ...

There are well-established processes for virus clearance from recombinant proteins in downstream processes including inactivation by low pH, anion and cation exchange chromatography and virus retention filtration.  The typical approach is to calculate the log retention values across each step and sum up at the end for the entire process.  If one is using ...

Protein A is a well-established method for the initial capture and purification step for monoclonal antibody production. A number of factors should be considered when selecting a protein A resin. Our experts weigh in.

Our group is responsible for clinical phase antibody downstream process development, scale-up, tech transfer and manufacturing support. A key challenge is to eliminate bottlenecks that result from higher bioreactor titers.  We are getting multiple grams per liter titer and this shifts the process bottlenecks to the downstream, making ...

As bioreactor titers increase, so does the pressure on downstream steps to effectively process the upstream feed. At the same time, downstream steps must become more cost effective. Given this challenging environment, selection of the optimum protein A resin for initial capture and purification of monoclonal antibodies is critical. The first criterion by which protein A resins are evaluated is typically ...

High throughput, parallel screening of chromatography resins and operating parameters such as conductivity and pH is routinely conducted by producers of monoclonal antibodies.  Well-established approaches use batch mode screening in 96-well plates.  Miniaturized “robo-columns” are increasingly used in process development to more rapidly scout operating space and optimize chromatographic conditions.  Despite innovations in high throughput screening, challenges remain such as ...