Intertek Explores the Reformulation of Intravenous Biologics

Intertek announced on Dec. 1, 2015 that it plans to explore needle-free, alternative drug delivery routes of administration for its clients that manufacture biologics. Stability and degradation issues are common with biologics, and Intertek is researching ways to “overcome the challenges in both formulation and testing” of medications manufactured in living cells. They plan to specifically focus on reformulating biologics for pulmonary and intranasal delivery, which may help resolve some biologic product issues related to safety, bioavailability, and patient adherence. Additionally, because biologics are susceptible to enzymatic degradation-making oral delivery difficult-inhaled formulations may be one of the most promising routes of drug delivery for large-molecule products.

Intertek’s inhalation expert, Mark Parry, has been actively engaged in the study of how biologics can be successfully delivered into the body via a metered dose inhaler. Parry and his colleagues have conducted investigational studies using both adult and pediatric versions of an idealized throat to examine the concentration of drug particles (i.e., the emitted dose) that is distributed inside the airways. Parry was also involved in a study on formulating powder blends for different inhaler devices, which was published in July 2015 in the International Journal of Pharmaceutics. In that study, Parry et al. concluded that inhaler formulations must be co-optimized with the inhaler devices during product development.

Ashleigh Wake, biopharmaceutical services leader at Intertek, said in a press release that the development of inhaled biologics brings together two of Intertek’s main strengths, which include “formulation development for inhalation technologies and biological product characterization, in particular, applying methodologies to assess potential degradation routes such as aggregation, truncation, and deamidation."