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
Molecular Biology Techniques and Applications·Molecular Biology·Biochemistry, Genetics and Molecular Biology·Life Sciences
References
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- Christopher J. Roberts; Therapeutic protein aggregation: mechanisms, design, and control. Trends Biotechnol. 2014, 32, 372-380. [CrossRef]
- Gary Walsh; Eithne Walsh; Biopharmaceutical benchmarks 2022. Nat. Biotechnol. 2022, 40, 1722-1760. [CrossRef]
- 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. [CrossRef]