QC Testing & QP Release
Clinical products and IMPs are sampled and analysed according to prepared pre-approved specifications using methodology developed and validated in-house. Release of products by our in-house QP is performed before distribution to the clinical sites.
Implementation of an established approach, using technologies to fully characterise both molecular level properties and bulk properties, can be applied either predictively, for optimisation purposes or for inclusion in regulatory documentation. These technologies can be applied during clinical development or to materials already in the market place. With respect to drug substance, close collaboration between CMC and API teams will ensure determination of the most appropriate form for pharmaceutical application, offering a long term view to successful project progression. Similarly, characterisation of excipients, or drug – excipient interactions, either throughout the recommended manufacturing process or in the final product, can be employed to ensure robust performance
The identification of drug impurities or their degradation products is an integral part of the drug development process. Impurities in drug substances and drug products typically arise from synthesis and/or are degradants. However, some impurities, which are highly reactive because of their structure, have the potential to interact with DNA.
A mutagenicity assessment must be performed for all confirmed impurity/degradant structures found during the scientific evaluation of investigational drug substances and products in order to comply with ICH M7 guidance. Arcinova has the capability to arrange these assessments using a range of different software tools.
Linked to our expertise in chromatographic separation/isolation, on-site high field NMR, accurate mass spectrometry and synthetic capabilities, Arcinova scientists can offer a complete service for the identification and if relevant, chromatographic response factor determination, for impurities and degradation products of concern. This service can be accessed on a stand-alone basis or as part of an integrated CMC service.
Bio2Business 2018Bio2Business Basel 2018 will be attended by Nathalie Huther, Business Development Manager Europe.
Bio2Business 2018Dates: 19th - 20th JuneLocation: Basel, Switzerland
ChemSpec EuropeThe ChemSpec Europe Conference will be attended by Gareth Jenkins, Chief Scientific Officer at Arcinova. Gareth has been invited to chair 'Sessions 3 and 5' for the Royal Society of Chemistry's Special Symposium, during the two-day event.
ChemSpec EuropeDates: 20th - 21st June 2018Location: Cologne, Germany
Scale-up of Chemical Processes ConferenceThe Scale-up of Chemical Processes Conference will be attended by Nathalie Huther, Business Development Manager Europe.
Scale-up of Chemical Processes ConferenceDates: 25th - 27th JuneLocation: Prague