Recent biopharmaceutical applications of capillary electrophoresis methods on recombinant DNA technology-based products

Kaya S. I., Cetinkaya A., ÇAĞLAYAN M. G., ÖZKAN S. A.

ELECTROPHORESIS, cilt.43, sa.9-10, ss.1035-1049, 2022 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Derleme
  • Cilt numarası: 43 Sayı: 9-10
  • Basım Tarihi: 2022
  • Doi Numarası: 10.1002/elps.202100193
  • Dergi Adı: ELECTROPHORESIS
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Aerospace Database, BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Chimica, Communication Abstracts, EMBASE, Food Science & Technology Abstracts, MEDLINE, Metadex, Veterinary Science Database, Civil Engineering Abstracts
  • Sayfa Sayıları: ss.1035-1049
  • Anahtar Kelimeler: Biopharmaceuticals, Capillary electrophoresis, Characterization, Recombinant DNA technology, Separation, MONOCLONAL-ANTIBODY VARIANTS, SODIUM DODECYL-SULFATE, INTACT MASS ANALYSIS, ZONE-ELECTROPHORESIS, CHARGE VARIANTS, N-GLYCANS, THERAPEUTIC ANTIBODIES, MIDDLE-UP, TRANSIENT ISOTACHOPHORESIS, MIGRATION TECHNIQUES
  • Ankara Üniversitesi Adresli: Evet

Özet

Biopharmaceuticals (recombinant technology-based products, vaccines, whole blood and blood components, gene therapy, cells, tissues, etc.,) are described as biological medical products produced from various living sources such as human, microbial, animal, and so on by manufacturing, extraction, or semi-synthesis. They are complex molecules having high molecular weights. For their safety and efficacy, their structural, clinical, physicochemical, and chemical features must be carefully controlled, and they must be well characterized by analytical techniques before the approval of the final product. Capillary electrophoresis (CE) having versatile modes can provide valuable safety and efficacy information, such as amino acid sequence, size variants (low and high molecular weight variants), charged variants (acidic and basic impurities), aggregates, N-linked glycosylation, and O-linked glycosylation. There are numerous applications of CE in the literature. In this review, the most significant and recent studies on the analysis of recombinant DNA technology-based products using different CE modes in the last ten years have been overviewed. It was seen that the researches mostly focus on the analysis of mAbs and IgG. In addition, in recent years, researchers have started to prefer CE combined mass spectrometry (MS) techniques to provide a more detailed characterization for protein and peptide fragments.