Intertek researches formulation strategies to repurpose biologic drugs

Achieving improvements in safety, efficacy and convenience for patients by using inhalation as an administration route

Intertek is researching the potential improvements in safety, efficacy and convenience for patients that can be achieved through redevelopment of biologics so that they can be administered through inhalation

Intertek, a leading quality solutions provider to industries worldwide, is researching the potential improvements in safety, efficacy and convenience for patients that can be achieved through the redevelopment of biologic medicines so that they can be administered to patients through inhalation.

The background to the research stems from the fact that while biologic drugs are a vital class of modern medicines, the vast majority of these are administered by repeated injection. The cost and patient discomfort has spurred research efforts towards alternative possibilities that provide a more comfortable patient experience while also bringing improvements in safety and efficacy of the medicine. While therapeutic biologics are very effective, they are also susceptible to degradation through exposure to environmental factors such as temperature, physical stresses and interaction with surfaces, which makes the manufacture, processing and delivery of these products more challenging than conventional pharmaceuticals.

Intertek is currently researching the formulation of biopharmaceuticals for inhaled or nasal delivery for a number of global clients in order to achieve needle-free alternative routes of administration with direct delivery to the respiratory system. With strengths in inhalation technology, formulation development, excipient compatibility, method development and validation, and biologic stability testing, these specialist capabilities are being focused on helping clients overcome the challenges in both formulation and testing of these products.

We believe that the future of biopharmaceutical administration will progressively shift from injection to more user-friendly routes

Mark Hammond, Intertek Pharmaceutical Services Leader, said: 'We believe that the future of biopharmaceutical administration will be progressively shifted from injection to more user-friendly routes, such as inhalation. Intertek’s research benefits our clients’ to help them bring to market safer, more effective drug delivery that offers the patient a much better experience.'

Intertek inhalation expert, Mark Parry, will discuss this topic at the Drug Delivery to the Lungs 26 Conference, 9-11 December 2015, Edinburgh, during his presentation, 'Formulation of Biologics for Inhaled and Nasal Delivery'.

Ashleigh Wake, Intertek Biopharmaceutical Services Leader, said: 'The administration of biologics is extremely challenging because of their inherent instability, which can affect the efficacy and safety of the drug. The development of inhaled biologics brings together two of our core strengths; formulation development for inhalation technologies and biological product characterisation, in particular, applying methodologies to assess potential degradation routes such as aggregation, truncation and de-amidation.'

With more than 15 years of services provision supporting both inhalation and biologics drug development, Intertek also provides pharmaceutical development and manufacturing support services spanning analysis, bioanalysis, formulation development, regulatory consultancy, auditing and supply chain management solutions from its network of offices and regulatory laboratories across the globe.