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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

Mutagenic Impurities 

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. 

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