Lonza has launched DonorPlex Hepatocytes, a new line of high-quality cryopreserved pooled donor suspension hepatocytes, which are the first of their kind to be produced using the company's novel patented manufacturing process. Researchers within DMPK and ADME laboratories can now benefit from this reliable and robust product offering for studying the hepatic metabolism of drugs.
Understanding hepatic drug metabolism is necessary to meet the strict safety-testing requirements for market approval of new products. Researchers typically need to use primary cryopreserved hepatocytes from a large number of donors to obtain a statistically significant result. However, pooled donor hepatocytes currently available on the market commonly suffer from increased lot-to-lot variability, while not being able to meet more specialised application needs.
Lonza’s manufacturing process ensures that the DonorPlex Hepatocytes exhibit improved phenotype reproducibility. Furthermore, a proprietary algorithm that predicts yield, viability and functional phenotype prior to manufacture ensures individual customer specifications are met.
"Drug discovery scientists require access to high-quality hepatocytes that can deliver consistent and dependable results to expedite new product approval," said Dr. Maureen Bunger, Product Manager for ADME-Tox Solutions at Lonza. "The DonorPlex Hepatocytes have been designed to do just that. Our patented pooling procedure, in combination with our predictive algorithm, means we can provide our customers with a variety of hepatocyte configurations and sizes that either represent the average population or meet specific metabolism testing and cytochrome P450 (CYP) activity needs."
The DonorPlex Hepatocytes offer a large, comprehensive inventory of cryopreserved single donor suspension hepatocytes, which include a range of 10-, 20- and 50-donor gender-specific and mixed-gender lots.