Monoclonal antibody therapeutics continues to grow exponentially in the biologics research field, but there are still countless challenges within the development, characterization, and testing phases. For example, labs are experiencing additional requests for characterization and analysis due to the following reasons:
- An increasing number of MAb candidates are entering the clinical pipeline
- Improvements in upstream processes (cell culture and purification process development and formulation screening) are causing bottlenecks in the analytical throughput
- Strict Quality-by-Design (QbD) guidelines are requiring enhanced antibody characterizations
Here, we offer four tips to improve and increase MAb analysis:
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- Optimize LC/MS interfacing by using a reversed-phase monolith column. These columns are ideal for the fast separations of proteins by capillary liquid chromatography. Read (and download) Application Note 240 for more information on how this can help you.
- Automate fraction collection and post-acquisition analysis. Here is a downloadable PDF on the development of an automated method.
- Consider a bioinert system to prevent metal poisoning of your columns. Visit this page for some excellent suggestions. Also, consider if your stainless steel HPLC system is generating rust.
- Are you observing pressure increases at higher pHs during MAb pH gradient separations? This issue arises with grafted ion-exchange polymer columns. You might want to consider using a nonporous pellicular resin column, such as the MAbPac SCX-10 column.
You can also receive regular updates on improved methods and processes and new Tips & Tricks by subscribing to our monthly MAb Solutions eNewsletter.