Genetic Engineering & Biotechnology News Webinar

Webinar Date: Tuesday, May 14, 2024

Webinar Time: 11 AM ET / 8 AM PT

The development of a biosimilar drug involves analyzing numerous samples from various cell lines. Critical quality attributes (CQAs) are characterized for each sample, such as glycosylation and charge variants. Traditional methods, like ion exchange chromatography, are labor-intensive and rely on optical detection to measure the acidic and basic variants’ peak areas. However, it’s also important to identify the specific charge variants to detect any potentially harmful alterations in the samples. This process can be time-consuming and requires a significant amount of materials. Therefore, accurately characterizing the critical quality attributes of each sample is essential for ensuring the safety and efficacy of the biosimilar drug.

Another method to analyze the charge heterogeneity is through the combination of microfluidic capillary electrophoresis and mass spectrometry (CE-MS). This technology allows for minimal sample usage and quick analysis, with the addition of MS for identifying the charge variants and glycosylation profile of the native protein. This data is crucial for choosing the most biosimilar clone samples for continued process development.

In this webinar we show how the ZipChip is employed in Polpharma Biologics Utrecht BV for rapid early-stage clone screening. We illustrate this with a case study in which the ZipChip was used to select clonal cell lines based on their charge variants and their glycosylation profile. Furthermore, we highlight the use of the new CVA kit, which enabled better separation and sensitivity in charge variant analysis of biotherapeutics. 

Key Takeaways:

• Microfluidic CE-MS technology basics and applications 
• The benefits of combining charge variant separations with mass spec characterization 
• How this technology is an asset for rapid clone screening of biosimilar candidates in the biopharmaceutical industry 

Meet the Speakers