October 2016

Sekisui XenoTech Standardizes Lysosomal Test Systems for Biopharmaceutical Development

Author:  Dr. Chris Bohl, Michael Millhollen
Posted:  05 October 2016

Before releasing these test systems, there was not a high quality, specific, relevant, easy and ready to use, in vitro test system to monitor stability/catabolism of targeted biotherapeutics like there was for small molecule compounds (i.e. microsomes). As the target biotherapeutic strategies become further developed and more common in development pipelines, there will be an increased need to be able to quickly and conveniently test the characteristics of candidate molecule/modifications prior to testing them in more complicated, time consuming, and more costly test systems.

Lysosomes are an important in vitro diagnostic tool because they are the most representative test system available, as they are the organelle that is being targeted by designers to be the site of activation by taking advantage of unique characteristics inherent to lysosomes. Development groups have had to rely on purified recombinant enzymes, cell homogenates, or cell lines engineered to overexpress certain proteins to acquire reagents to test biotherapeutics’ metabolism. While these systems offer certain favorable characteristics, they cannot replicate the environment that compounds will encounter in the native lysosome, nor do they take into account inherent differences between primary human tissue and cell lines. While the isolated lysosomes that we offer are disrupted and no longer offer structural characteristics of lysosomes, they offer a complete and stoichiometrically correct enrichment of lysosomal contents from human primary tissue.

Currently, we are seeing the most demand from researchers that are developing ADCs, RNAi technologies, and immunotherapies...

Read more or view our lysosomal products

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