Recombinant biopharmaceuticals are biologically active macromolecular medicinal products generated by expression of engineered genetic sequences. For protein products, manufacture must preserve the folded molecular state during recovery, formulation, and storage [1]. Their molecular composition includes the encoded amino acid sequence and post-translational modifications introduced by the production system, such as glycosylation, sulfation, or amidation [2]. Partially unfolded molecules can associate into aggregates, creating additional structural heterogeneity within a preparation [3]. The category includes recombinant antibodies, enzymes, hormones, and other protein products produced in biological expression platforms [4]. Characterization therefore considers sequence identity, assembly, modification profiles, and biological activity. Cultivation and downstream processing establish the final population of molecular forms present in the finished recombinant product [5].
- recombinant proteins
- biopharmaceuticals
- expression hosts
- post-translational modifications
References
- Sven Frokjaer; Daniel E. Otzen; Protein drug stability: a formulation challenge. Nat. Rev. Drug Discov. 2005, 4, 298-306, 10.1038/nrd1695.
- Gary Walsh; Roy Jefferis; Post-translational modifications in the context of therapeutic proteins. Nat. Biotechnol. 2006, 24, 1241-1252, 10.1038/nbt1252.
- Christopher J. Roberts; Therapeutic protein aggregation: mechanisms, design, and control. Trends Biotechnol. 2014, 32, 372-380, 10.1016/j.tibtech.2014.05.005.
- Gary Walsh; Eithne Walsh; Biopharmaceutical benchmarks 2022. Nat. Biotechnol. 2022, 40, 1722-1760, 10.1038/s41587-022-01582-x.
- Amani Elsayed; Nisrein Jaber; Mayyas Al-Remawi; Khalid Abu-Salah; From cell factories to patients: Stability challenges in biopharmaceuticals manufacturing and administration with mitigation strategies. Int. J. Pharm. 2023, 645, 123360, 10.1016/j.ijpharm.2023.123360.