Aimed at both biologics and small molecules
Intertek, the leading quality solutions provider to industries worldwide, has launched comprehensive services for orally inhaled and intranasal drug products (OINDPs).
Following the acquisition of Melbourn Scientific, Intertek is able to offer a unique development, formulation and characterisation service to its clients who are looking to deliver both biomolecules as well as traditional small molecule drug products.
Though centres of excellence, Intertek can offer an integrated service solution covering formulation, analytical method development and validation, drug product physical characterisation, Chemistry, Manufacturing and Controls (CMC) support, stability studies and QC release testing. Its experts also provide regulatory affairs consultancy, bioanalysis and extractables and leachables studies for all types of inhalation medicine products.
There is a global increase in demand for development of more patient friendly drug delivery methods such as OINDP for optimum therapeutic efficacy and efficiency and enhanced patient outcomes. During the development of these products specialist capabilities and test facilities are required for techniques such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI), spray pattern/plume geometry and delivered dose assessment.
One particular challenge in OINDP development is the control of extractables and leachables (E&L). With inhaled administration routes that deliver medication directly to the lungs the rubber and plastic inhaler device components are in constant contact with the product formulation with a potential for substances to leach from the device components into the drug product. Intertek’s experts regularly provide E&L studies supporting OINDP development.
Intertek’s regulatory facilities in Europe and the US, which are regularly inspected by the UK Medicines and Health Regulatory Authority (MHRA) and the US FDA, offer these comprehensive service packages assisting clients through the strategic development of novel orally, inhaled or nasally delivered bio/pharmaceutical products.
'The combination of expertise in OINDP development, formulation, bioanalysis, analytical testing and our advanced capabilities for measuring drug/device interaction provides a unique offering to clients working with both small and large molecule medicines,' said Mark Hammond, CEO Intertek Melbourn.