Background Introduction of biological disease-modifying antirheumatic drugs (DMARDs) that began with the approval of the tumour necrosis factor (TNF) inhibitor etanercept has revolutionized the management of patients with rheumatic diseases1 and other inflammatory diseases.2 Use of biological therapy, including TNF inhibitors, has improved outcomes for patients with RA, with sustained remission now considered the optimal treatment goal to prevent joint damage.1 Therefore, flexible and convenient treatment options that are compatible with modern lifestyles are important aspects in helping patients maintain treatment and manage their disease. Since the introduction of etanercept, Pfizer has aimed to provide this through innovation in the form of lyophilized powder for solution injection, pre-filled syringe and pre-filled pen formulations.3 Regulation of the manufacture of etanercept and other biologic drugs is governed by a requirement to perform robust analytical and stability testing to ensure quality is maintained.4 Due to its structural complexity, etanercept, as with many other biologics, is typically stored under refrigerated conditions.3 Here we describe the stability testing data that support an alternative storage condition for etanercept at ambient temperature, representing further innovation in the product lifecycle aimed at enhancing patient convenience.
Objectives To generate a comprehensive analytical data package from stability testing of key quality attributes consistent with regulatory requirements that determine if the product profile of etanercept is maintained at an alternative storage condition of ambient temperature.
Methods Test methods assessing the key attributes of purity (Size Exclusion High Performance Liquid Chromatography, Hydrophobic Interaction Chromatography), quality (appearance, pH, etanercept concentration by ultraviolet absorbance spectroscopy, particulate matter, reconstitution time, functionality), potency (cell-based TNF alpha-induced apoptosis bioassay) and safety (sterility, container closure integrity).
Results Results and statistical analysis from stability testing across all etanercept presentations showed key stability indicating parameters were within acceptable limits through the alternative storage condition of 25°C ±2°C for a period of 1 month.
Conclusions Stability testing performed in line with regulatory requirements supported a single period of storage for etanercept at an alternative storage condition of 25°C ±2°C for up to 1 month within the approved expiry of the product. This alternative storage condition for etanercept provides greater flexibility for patients, particularly whilst travelling with etanercept, reflecting Pfizer's commitment to offer enhanced overall patient convenience.
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CPMP guideline on stability testing (2003).
Disclosure of Interest S. Vicik Shareholder of: Pfizer, Employee of: Pfizer, J. Daffy Employee of: Pfizer, H. Jones Shareholder of: Pfizer, Employee of: Pfizer, A. Paulson Shareholder of: Pfizer, Employee of: Pfizer, E. Shannon Employee of: Pfizer