Many of today's biopharmaceutical formulations may potentially suffer from oxidation to some degree. Large molecule formulations are relatively more delicate and may be prone to degrade in the presence of oxygen. Besides a loss of efficacy and reduction in shelf life, exposure of such products to oxygen can result in product discoloration, changes in dissolution rate and profile, and even toxicity or other pharmacological properties associated with negative side effects. During the development of an oxygen-sensitive product, studies are performed that investigate the formulation’s interaction with oxygen. End-of-shelf-life stability studies verify that the product indeed retains efficacy under specified headspace oxygen levels. Such studies allow for the specification of appropriate initial headspace oxygen levels in the primary packaging.
Unfortunately, existing analytical methods for measuring oxygen in the headspace of parenteral containers are slow and/or destructive. This results in headspace oxygen analysis which is both time and resource intensive. Conventional destructive techniques, such as electrochemical methods or gas chromatography, are lab-based methods requiring ongoing consumables and specialized operator expertise to assure reliable measurements. The destructive nature of the measurement also means that these conventional methods cannot be used to monitor the oxygen consumption of a single sample over time. In addition, valuable product material is destroyed and costs are also incurred in the simple disposal of the analyzed samples.
LIGHTHOUSE platforms for rapid non-destructive headspace oxygen analysis can help streamline stability study activities. The rapid measurement technique allows for quick and efficient stability studies and requires no specialized operator expertise. The non-destructive nature of the measurement saves QC product samples that may be in limited supply and allows for the accurate monitoring of the oxidation of a single sample over time.