Trends in Light and Temperature Sensitivity Recommendations among Licensed Biotechnology Drug Products

Jennifer J Kim; Jordan D Pritts; Mai Ngo; Corey R Estoll; V Ashutosh Rao

doi:10.1007/s11095-023-03494-0

Trends in Light and Temperature Sensitivity Recommendations among Licensed Biotechnology Drug Products

Pharm Res. 2023 Jun;40(6):1491-1505. doi: 10.1007/s11095-023-03494-0. Epub 2023 Apr 6.

Authors

Jennifer J Kim¹, Jordan D Pritts², Mai Ngo^{2

3}, Corey R Estoll¹, V Ashutosh Rao⁴

Affiliations

¹ Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
² Laboratory of Applied Biochemistry, Division of Biotechnology Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave / Bldg. 52/72 Rm 2212, Silver Spring, MD, 20993, USA.
³ Virginia Commonwealth University School of Pharmacy, Richmond, VA, USA.
⁴ Laboratory of Applied Biochemistry, Division of Biotechnology Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave / Bldg. 52/72 Rm 2212, Silver Spring, MD, 20993, USA. ashutosh.rao@fda.hhs.gov.

Abstract

Purpose: Inherent structural and functional properties of biotechnology-derived therapeutic biologics make them susceptible to light- and temperature-induced degradation and consequently can influence their quality. Photosensitivity of therapeutic proteins continues to be examined, but the commonalities and trends of storage conditions and information about light and temperature sensitivity among currently licensed therapeutic proteins has not been previously surveyed.

Methods: Using a comprehensive and relational database approach, we conducted a scientific survey of all licensed biotechnology-derived drug products with the goal of providing evidence-based information about recommended storage conditions of formulations sorted by light- and temperature-related attributes as described for each product at licensure.

Results: We report the prevalence of indications for light and temperature sensitivity in formulations categorized by their presentation type, number of doses, container type, dosage form and active molecule type. We also report the storage temperature range across formulations and diluents for reconstitution and dilution. Formulations with excipients that potentially facilitate light-induced and thermal degradation were also noted.

Conclusions: The result of our analysis indicates that light and temperature sensitivity are prevalent across therapeutic protein formulations. However, when a formulation is reconstituted or diluted, both light and temperature sensitivity are less clear. In addition, light and temperature sensitivity are more well defined in liquid formulations than lyophilized powder formulations, and more well defined in products manufactured in autoinjectors, prefilled-syringes, and pens than products in vials. Overall, our report provides a data-driven summary of storage conditions among therapeutic protein formulations to support the development of future biologic drug products.

Keywords: biotechnology; formulation; photodegradation; photostability; protein.

MeSH terms

Biotechnology
Drug Stability*
Drug Storage
Light*
Temperature*