Drug Discovery & Pharmaceuticals
New Pooled Donor Suspension Hepatocytes Enables Reproducibility
Lonza announces the launch of DonorPlex™ Hepatocytes, a new line of high-quality cryopreserved pooled donor suspension hepatocytes, which are the first of their kind to be produced using Lonza’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 patented 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. “Lonza’s 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.
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New Project to Improve Diagnosis and Treatment of Ovarian Cancer
Porvair Sciences reports on its involvement in a new £2.6 million project led by Swansea University that aims to dramatically improve the diagnosis and treatment of ovarian cancer.
This project will involve collaboration with 5 key industrial partners - Porvair Sciences, Bruker UK, GE Healthcare UK, Axis Bio and GlaxoSmithKline (GSK). A new Antibody Drug Conjugates company will join the project in its second year. Antibody Drug Conjugates (ADC’s) are a powerful new class of therapeutics in medical oncology, where antibodies that target specific cancers are coupled with cytotoxic agents. The Cluster for Epigenomic and Antibody Drug Conjugate Therapeutics (CEAT) project aims to utilise novel epigenetic drugs and ADC’s to manipulate chemical compounds thus creating a new route for the treatment of ovarian cancer.
Utilising its proprietary Chromatrap® bead-free Chromatin Immunoprecipitation (ChIP) technology, Porvair Sciences will develop new epigenomic profiling approaches that will deliver the required advances in cutting-edge drug development and patient profiling. Using the Chromatrap® technology, Porvair Sciences will work with Swansea University and industrial partners to identify and characterise epigenetic drugs that are effective in preventing cancer development in ovarian cancer models. In addition, Porvair Sciences will support the evaluation of the Antibody Drug Conjugates (ADCs) resulting from the CEAT project.
CEAT principal investigator, Dr Lewis Francis from Swansea University’s School of Medicine, commented: “Epigenetics involves chemical changes to the DNA and associated proteins that can lead to genes being turned on or off. In some cases, this can go wrong and lead to disease. Through the CEAT project, Swansea University will work closely with CEAT partners to develop drugs that can control epigenetic signals; these epigenetic drugs can be targeted specifically towards ovarian cancer cells where epigenetic changes have occurred.”
Amy Johnson, Business and Technical Development Manager at Porvair Sciences, commented: “We are delighted to be involved with the CEAT project. This is a great opportunity for the project to leverage our bead-free ChIP technology and expertise to be at the forefront of developing epigenetic-based cancer therapies.”
More information online:
ilmt.co/PL/lygq 48640pr@reply-direct.com Class-leading Sanitary Seals Excel in Food and Pharmaceutical Applications
The DuPont™ Kalrez® LS390 series of perfluoroelastomer sanitary seals have been designed specifically for use in sectors that include life science, food and beverage, and pharmaceutical. Class-leading Kalrez® LS390 provides longer seal life and tighter sealing, which improves productivity and process optimisation. Moreover, the new seals create a safer environment in the day-to-day running of process plants and manufacturing facilities. Kalrez® LS390 seals are available in the UK from authorised distributor Dichtomatik Ltd.
There are a number of problems that can be experienced in sanitary seal applications, many of which are related to thermal and chemical resistance challenges, compression set (permanent deformation), and high static friction (stiction). Such issues can lead to intrusion in the production line or dead space, which in turn elevates the risk of contamination or leakage.
Kalrez® LS390 has been purpose-designed to overcome these common challenges by providing high hardness properties (Shore A3 88), low stiction, temperature resistance up to 220°C and outstanding chemical resistance to process chemicals, WFI (water for injection), and SIP and/or CIP processes. For users, these properties facilitate greater MTBR (mean time between repair), delivering bottom-line cost savings.
Among early adopters of the parts is a major pharmaceutical plant in Japan. Here, Kalrez® LS390 has successfully been deployed in an infusion-drop product operation that uses pure steam SIP. The manufacturer chose Kalrez® LS390 because of its improved chemical resistance and low stiction performance.
Problems had been experienced previously with the company’s existing material (silicone rubber seals), which had issues with steam resistance and high stiction, resulting in a short maintenance period of six months. However, after switching to Kalrez® LS390, the performance improvements have been substantial; the sanitary seals provide excellent resistance to chemicals and pure steam SIP, lasting a year without any damage on the contacting surface. These performance attributes have helped to increase productivity, lower maintenance costs and minimise unscheduled downtime, resulting in lower TCO (total cost of ownership).
As a result of their unique grey colour, LS390 sanitary seals offer easy identification for correct material selection and application. The perfluoroelastomer can also be used in applications other than sanitary seals. To discuss this possibility, please in the first instance contact Dichtomatik Ltd.
More information online:
ilmt.co/PL/ALLZ 48577pr@reply-direct.com
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