Reducing time to market with
Analytical chemistry
Dr Ramesh Jagadeesan , senior director for analytical development at Recipharm , discusses innovative approaches to optimise analytical chemistry and explores the advantages
Innovative thinking offers many
benefits to analytical chemistry , such as reduced timelines in delivering vital medicines to patients and improved efficiencies . As well as considering small- and large-scale projects in terms of their analytical requirements , it presents the industry with the opportunity to increase speed-to-market . With drug developers shifting their focus to concentrate on core capabilities and therefore redirecting resources , the outsourced analytical services market is growing . Pharmaceutical firms are turning to stand-alone service providers and CDMOs to support them with their analytical requirements , due to increasing time pressures and inhouse limitations . The introduction of stricter obligations from regulatory agencies for more analytical details on medicines and process development is also contributing to the need for improved analytical strategies .
Services in demand
CDMOs are actively seeking innovative ways of offering customers more value . Traditionally , manual processes ( including manual injection and integrators ) have involved analysts sitting by equipment until each run has finished , which can result in delays at each stage of product development . Now , the emergence of more systematic approaches means that the automation of analytical instrumentation is becoming a reality . The length of time required for QC testing is being reduced through automation and the emergence of innovative technologies . For example , automated titrations with 21 complement fixation tests and e-sign-off features can greatly reduce analysis time . Through automated methods , an estimate of iodine , iodide and iodate content in a range of formulations can be made . The use of an auto-titrator allows the analysis of three times more samples when compared to a manual approach , reviewing raw data and granting approval electronically . Previously , analyses have been carried out to determine what has been added to formulations , such as assays . New techniques now make it possible to estimate unexpected additions in formulations . This includes elemental impurities generated through manufacturing vessels and reactants . Elemental analysis has traditionally used classical analysis , including heavy metal tests and limits of arsenic . This is now being phased out and replaced with modern analytical techniques ,
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981