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纯度 | >90%SDS-PAGE. |
种属 | Human |
靶点 | QA |
Uniprot No | P02745 |
内毒素 | < 0.01EU/μg |
表达宿主 | E.coli |
表达区间 | 1-245aa |
氨基酸序列 | MEGPRGWLVLCVLAISLASMVTEDLCRAPDGKKGEAGRPGRRGRPGLKGEQGEPGAPGIRTGIQGLKGDQGEPGPSGNPGKVGYPGPSGPLGARGIPGIKGTKGSPGNIKDQPRPAFSAIRRNPPMGGNVVIFDTVITNQEEPYQNHSGRFVCTVPGYYYFTFQVLSQWEICLSIVSSSRGQVRRSLGFCDTTNKGLFQVVSGGMVLQLQQGDQVWVEKDPKKGHIYQGSEADSVFSGFL |
预测分子量 | 26 kDa |
蛋白标签 | His tag N-Terminus |
缓冲液 | PBS, pH7.4, containing 0.01% SKL, 1mM DTT, 5% Trehalose and Proclin300. |
稳定性 & 储存条件 | Lyophilized protein should be stored at ≤ -20°C, stable for one year after receipt. Reconstituted protein solution can be stored at 2-8°C for 2-7 days. Aliquots of reconstituted samples are stable at ≤ -20°C for 3 months. |
复溶 | Always centrifuge tubes before opening.Do not mix by vortex or pipetting. It is not recommended to reconstitute to a concentration less than 100μg/ml. Dissolve the lyophilized protein in distilled water. Please aliquot the reconstituted solution to minimize freeze-thaw cycles. |
以下是关于重组蛋白质量分析(QA)的模拟参考文献示例(非真实文献,供参考格式):
1. **《Analytical strategies for characterization and quality control of therapeutic recombinant proteins》**
- 作者:Smith, J., & Lee, A.
- 摘要:综述了重组蛋白药物的关键质量属性分析方法,包括质谱、HPLC和生物活性检测,强调多方法联用对确保产品一致性的重要性。
2. **《Stability profiling of recombinant antibodies: Impact of formulation and storage conditions》**
- 作者:Wang, Y., et al.
- 摘要:研究不同制剂和储存条件对抗体稳定性的影响,提出基于动态光散射和SEC-HPLC的降解产物监测策略。
3. **《Enhancing recombinant protein expression in E. coli through codon optimization and host engineering》**
- 作者:Gupta, R., & Zhang, T.
- 摘要:通过密码子优化和大肠杆菌宿主改造提高蛋白表达效率,并评估产物溶解度及翻译后修饰的准确性。
4. **《Regulatory considerations for biosimilar recombinant proteins: Analytical comparability and beyond》**
- 作者:EMA Technical Committee
- 摘要:讨论生物类似药开发中分析可比性要求,涵盖结构表征、效价测定及临床前验证的关键步骤。
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建议通过PubMed、Google Scholar等平台检索关键词“recombinant protein quality control”、“therapeutic protein characterization”获取真实文献。近年高被引论文多聚焦于:
- 高分辨率质谱在翻译后修饰分析中的应用
- 人工智能驱动的稳定性预测模型
- 新型快速检测技术(如微流控芯片)
**Background of QA-Recombinant Proteins**
Recombinant proteins, engineered through genetic modification, are pivotal in biotechnology, medicine, and research. QA (Quality Attribute)-focused recombinant proteins emphasize stringent control over critical quality attributes (CQAs) such as purity, stability, activity, and post-translational modifications (PTMs). These proteins are produced using host systems (e.g., *E. coli*, yeast, mammalian cells*) to express target genes, followed by purification and characterization to meet predefined quality standards.
The development of QA-recombinant proteins stems from the demand for consistency in therapeutic applications, including monoclonal antibodies, vaccines, and enzymes. For instance, biologics like insulin or erythropoietin require precise glycosylation patterns and folding to ensure efficacy and safety. Regulatory agencies (e.g., FDA, EMA) mandate rigorous quality control, driving innovations in expression systems, purification techniques (e.g., affinity chromatography), and analytical methods (e.g., mass spectrometry, SDS-PAGE).
Challenges include minimizing heterogeneity (e.g., aggregation, oxidation) and scaling production without compromising quality. Advances in synthetic biology, CRISPR editing, and high-throughput screening have enhanced host cell line engineering for optimal protein yield and PTM fidelity. Additionally, QA-recombinant proteins underpin diagnostic tools (e.g., ELISA kits) and industrial enzymes (e.g., biofuels), highlighting their versatility.
Future directions focus on next-gen platforms (e.g., cell-free systems, algal hosts) and AI-driven quality prediction models. By prioritizing QA, recombinant proteins continue to revolutionize precision medicine and sustainable biomanufacturing.
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