Comparing Traditional Aggregation Measurement Techniques to the Valita Aggregation Pure Assay
Aggregation is considered one of the key critical quality attributes (CQA) associated with monoclonal antibodies, especially in cell line development and process development when thorough assessment of aggregation is crucial.
Preventing protein aggregation in a timely manner is of great importance to the biopharmaceutical industry. However, certain methods like DLS/SLS and HPLC-SEC can take hours to produce results due to longer processing times and lower throughput. When dealing with hundreds or thousands of samples to create a commercially viable cell line, these hours accumulate and add unnecessary complexity to your workflow, ultimately affecting your time to market.
Fortunately, there’s a better way. The Valita Aggregation Pure assay is one of the fastest, easiest, and automatable protein aggregation screening assays available. In just three simple steps and as little as 15 minutes, you can prepare and measure a full 96-well plate.
The Valita Aggregation Pure Assay vs. HPLC-SEC
When comparing the performance of the Valita Aggregation Pure assay to HPLC-SEC it is clear that the Valita Aggregation Pure assay complements the use of size based screening technologies. The Valita Aggregation Pure assay offers a rapid, high-throughput technique for screening aggregation that correlates with HPLC-SEC. Using the Valita aggregation Pure assay allows you to reduce your testing turn-around time, acting as an effective funnel to narrow your clone pool earlier during clone screening.
Total aggregation (%) determined with Valita Aggregation Pure assay vs. HPLC-SEC
Figure 1: Industry partner data of 15 samples measured on HPLC-SEC and the Valita Aggregation Pure assay. HPLC-SEC results (% HMW) and Valita Aggregation Pure results (polarization) have been normalized to fit the same scale. Samples were categorically ranked. (n=3).
Insightful Resources
The Valita Aggregation Pure assay: A rapid and accurate alternative for aggregation quantification of purified monoclonal antibodies
Valita Aggregation Pure Assay Brochure
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