Introduction: This work aimed at reporting the extent to which 10% IVIg preparations differ in their purity profile and biological characteristics.
Material and Method Purity profile and biological characteristics of Tegeline® were compared to other marketed 10% IVIg (Privigen®, Octagam®, Gamunex®, and Kiovig®). For biochemical comparisons, Tegeline® batches used were performed with European plasma source, and for activity comparison, Tegeline® batches used were performed with US plasma. For competitors, commercial batches were performed using US plasma and are in compliance with regulatory requirements.
Results Anticomplementary activity (ACA) Variable levels of ACA were observed among the brands with intermediate levels for Tegeline®. Complement activation is known to induce fever, chills, and hypotension [1].
Functional characterization All compared batches are issued from US plasma. The results show no significant difference for all antibodies and functional activities.
Purity Purity assessment shows differences between these preparations: IgA contents are the highest for Octagam® (>1.4 mg/g Prot); IgA are intermediate for Gamunex®, Kiovig®; for Privigen® and Tegeline®, contents in IgA are very low (around 0.1 mg/gProt). Coagulant factors
Tegeline® exhibits the lowest Factor XI Ag content (102-109mEIU/mL) compared to competitors (151-338mEU/mL). Maximum Factor XI Ag content was observed with Privigen® (309mEIU/mL).
Conclusion: Although different IVIg preparations essentially consist of polyclonal IgG, the different purification processes lead to variations in other characteristics. The Tegeline® manufacturing process developed with a QbD approach [2] has generated a 10% IVIg with higher quality and enhanced safety profile while maintaining a high level of efficacy.
References 1. Spycher M, et al. Invitro comparison of the complement scavenging capacity of different intravenous immunoglobulin preparations. Vox Sang 2009; 97:348–354.
2. Philippe Paolantonacci, et al. Development of a Premium Quality Plasma-derived IVIg (IQYMUNE ®) Utilizing the Principles of Quality by Design – A worked-through Case Study. PDA J Pharm Sci Technol. Mar-Apr 2018;72(2):176-187.