Biochemical comparison of four commercially available C1 esterase inhibitor concentrates for treatment of hereditary angioedema.
Bottom Line: As no pharmacopoeia requirements exist for C1-INH concentrate lot release, biochemical characteristics as declared by the manufacturers may not be compared directly.Main protein bands were found for all plasma-derived products at approximately 105 kDa, and for Ruconest, at approximately 98 kDa.For harmonization of the analysis for drug release, we recommend the establishment of regulatory requirements for purity determination and the implementation of threshold levels in C1-INH concentrates.
Affiliation: Department of Preclinical Research and Development, Operations Support, CSL Behring, Marburg, Germany.Show MeSH
Related in: MedlinePlus
Mentions: SDS-PAGE revealed main protein bands for all plasma-derived C1-INH concentrates at approximately 105 kDa and for the transgenic product at approximately 98 kDa (Fig. 3). Additional band patterns were identical within the batches of a single product but differed among products. Among the plasma-derived C1-INH preparations, a band was found at approximately 64 kDa, which was less prominent for Berinert than for Cinryze and Cetor and was identified as α1-antichymotrypsin (Fig. 3, 1) by PMF analysis. Other nontherapeutic proteins included complement factor C3 in Cinryze and Cetor, immunoglobulin heavy constant mu in Berinert, and ceruloplasmin in all plasma-derived C1-INH concentrate samples (Fig. 3, 2). No coagulation factors were detected in any of the samples. The PMF confirmed that all bands detected in Ruconest were C1-INH protein or fragments of C1-INH.
Affiliation: Department of Preclinical Research and Development, Operations Support, CSL Behring, Marburg, Germany.