“The rationale behind releasing these products is that there is not a high quality, specific, relevant, easy and ready to use, in vitro test system to monitor stability/catabolism of targeted biotherapeutics like there is for small molecule compounds (i.e. microsomes),” Chris Bohl, Ph.D., Global Technical Support Manager for Sekisui XenoTech’s products, told Outsourcing-Pharma.com.
Bohl explained that as target biotherapeutic strategies become more common in development pipelines, there will be an increased need to quickly 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,” explained Bohl.
“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,” he added.
However, Bohl explained that while these systems offer “certain favorable characteristics,” they can’t replicate the environment that compounds will encounter in the native lysosome and they don’t account for 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,” said Bohl.
Currently, Bohl said the company is seeing the most demand from researchers that are developing ADCs, RNAi technologies, and immunotherapies.