Abstract
Transferon, a biotherapeutic agent that has been used for the past 2 decades for diseases with an inflammatory component, has been approved by regulatory authorities in Mexico (COFEPRIS) for the treatment of patients with herpes infection. The active pharmaceutical ingredient (API) of Transferon is based on polydispersion of peptides that have been extracted from lysed human leukocytes by a dialysis process and a subsequent ultrafiltration step to select molecules below 10 kDa. To physicochemically characterize the drug product, we developed chromatographic methods and an SDS-PAGE approach to analyze the composition and the overall variability of Transferon. Reversed-phase chromatographic profiles of peptide populations demonstrated batch-to-batch consistency from 10 representative batches that harbored 4 primary peaks with a relative standard deviation (RSD) of less than 7%. Aminogram profiles exhibited 17 proteinogenic amino acids and showed that glycine was the most abundant amino acid, with a relative content of approximately 18%. Further, based on their electrophoretic migration, the peptide populations exhibited a molecular mass of about 10 kDa. Finally, we determined the Transferon fingerprint using a mass spectrometry tool. Because each batch was produced from independent pooled buffy coat samples from healthy donors, supplied by a local blood bank, our results support the consistency of the production of Transferon and reveal its peptide identity with regard to its physicochemical attributes.
Highlights
Transferon, a human dialyzable leukocyte extract (DLE), is obtained by disrupting the cells from buffy coats, followed by a dialysis step using a 12 kDa cutoff membrane
DLEs have more than 50 years of clinical history as a treatment for several diseases [10], regulations concerning biological products and the use of pharmaceutical peptides have evolved significantly in recent years
Transferon is a human DLE that is manufactured in good manufacturing practices facilities and has been approved for human use by Mexican health regulatory agencies
Summary
Transferon, a human dialyzable leukocyte extract (DLE), is obtained by disrupting the cells from buffy coats, followed by a dialysis step using a 12 kDa cutoff membrane. Transferon is a biotherapeutic agent that has been approved by the Mexican health authorities for human consumption as an immunomodulator [1, 2]; continuous characterization and analysis of this agent are increasing our knowledge about its properties, supporting the quality of this product. DLEs have more than 50 years of clinical history as a treatment for several diseases [10], regulations concerning biological products and the use of pharmaceutical peptides have evolved significantly in recent years. A concerted effort has been made to determine their peptide composition. Several methods have been reported in attempt to determine the structure and composition of DLEs from various species [2, 11,12,13], such as a description of the amino acid content in pig and rabbit spleen-derived dialyzable extracts [14, 15], as well as bursaderived dialyzable extracts [12]; a conserved sequence has even been determined in DLEs from mice and calves [11, 16]
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