View the full list of references supporting this article in European Pharmaceutical Review, Issue 02 2026.
References
1. Shire SJ, Shahrokh Z, Liu J. Challenges In The Development Of High Protein Concentration Formulations. J Pharm Sci. 2004;93(6):1390-1402.
2. Platts L, Darby SJ, Falconer RJ. Control of Globular Protein Thermal Stability In Aqueous Formulations by the Positively Charged Amino Acid Excipients. J Pharm Sci. 2016;105(12):3532-3536.
3. Somani S, Jo S, Thirumangalathu R, et al. Toward Biotherapeutics Formulation Composition Engineering using Site-Identification by Ligand Competitive Saturation (SILCS). J Pharm Sci. 2021;110(3):1103-1110.
4. Boëffard-Dosierre L, Dagallier C, Eudier G, et al. NMR Detects Clustering and Ultra-Weak Excipient Interactions Governing Monoclonal Antibody Viscosity in Formulation-Relevant Conditions. mAbs. 2026;18(1):2685366.
5. Rodrigues D, Tanenbaum LM, Thirumangalathu R, et al. Product-Specific Impact of Viscosity Modulating Formulation Excipients During Ultra-High Concentration Biotherapeutics Drug Product Development. J Pharm Sci. 2021;110(3):1077-1082.
6. Lale SV, Goyal M, Bansal AK. Development of Lyophilization Cycle And Effect Of Excipients on the Stability of Catalase During Lyophilization. Int J Pharm Investig. 2011;1(4):214-221.
7. Forney-Stevens KM, Bogner RH, Pikal MJ. Addition Of Amino Acids To Further Stabilize Lyophilized Sucrose-Based Protein Formulations: I. Screening of 15 Amino Acids In Two Model Proteins. J Pharm Sci. 2016;105(2):697-704.
8. DailyMed. SAPHNELO (anifrolumab-fnia) Injection, Solution: Prescribing Information. 2026. US National Library of Medicine.



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