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Peng, Y. Recombinant Biopharmaceuticals. Encyclopedia. Available online: https://encyclopedia.pub/entry/61427 (accessed on 12 November 2026).
Peng Y. Recombinant Biopharmaceuticals. Encyclopedia. Available at: https://encyclopedia.pub/entry/61427. Accessed November 12, 2026.
Peng, Yu. "Recombinant Biopharmaceuticals" Encyclopedia, https://encyclopedia.pub/entry/61427 (accessed November 12, 2026).
Peng, Y. (2026, October 25). Recombinant Biopharmaceuticals. In Encyclopedia. https://encyclopedia.pub/entry/61427
Peng, Yu. "Recombinant Biopharmaceuticals." Encyclopedia. Web. 25 October, 2026.

Recombinant Biopharmaceuticals

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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
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References

  1. Sven Frokjaer; Daniel E. Otzen; Protein drug stability: a formulation challenge. Nat. Rev. Drug Discov. 2005, 4, 298-306. [CrossRef]
  2. Gary Walsh; Roy Jefferis; Post-translational modifications in the context of therapeutic proteins. Nat. Biotechnol. 2006, 24, 1241-1252. [CrossRef]
  3. Christopher J. Roberts; Therapeutic protein aggregation: mechanisms, design, and control. Trends Biotechnol. 2014, 32, 372-380. [CrossRef]
  4. Gary Walsh; Eithne Walsh; Biopharmaceutical benchmarks 2022. Nat. Biotechnol. 2022, 40, 1722-1760. [CrossRef]
  5. 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]
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Update Date: 25 Oct 2026
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