EPM News Update
Tepnel Pharma Services, part of Hologic, Inc., will introduce an expanded portfolio of regulatory compliant analytical services at CPhI. Two new analytical services will be introduced at the convention: the Global Batch and Lot Release Service for manufacturers of proprietary pharmaceuticals and biopharmaceuticals based outside of the EU; and the Invader Chemistry Platform (ICP) Genotyping Service that incorporates Hologic’s proprietary Invader and Invader Plus technology.
The Global Batch and Lot Release Service will provide quality control testing for the release of pharmaceuticals and biopharmaceuticals manufactured by companies outside the EU. This new service is targeted at companies that wish to establish a supply chain for authorised products within the EU member states.
The new ICP Genotyping Service uses a scalable technology (HT >30,000 samples/hr) that has a simple assay design and an affordable price, which can subsequently be developed into a genotyping assay for use in clinical practice. ICP is an isothermal, DNA probe-based system for highly sensitive, quantitative detection of specific nucleic acid sequences, which is both accurate and specific for the analysis of SNPs, InDels, CNV and gene expression that is designed to assist customers in the clinical trial, medical genetic and companion diagnostic (CDx) markets.
Stand 42B13
Tepnel Pharma Services, Hologic, Inc., carol.smith@hologic.com, +44 161 946 2220, www.tepnelpharmaservices.com / www.hologic.com.