是否无菌：是
胎牛血清是细胞培养体系中核心的天然营养添加剂，富含细胞生长、增殖、贴壁所需的生长因子、黏附蛋白、氨基酸、微量元素及多种活性调节因子，可高效维持体外细胞正常代谢与生理状态。 γ照射胎牛血清是在低温（全程≤-18℃）条件下，通过可控剂量的高能γ射线辐照进行终端灭菌的优质血清产品。其核心优势在于：无需加热即可高效灭活病毒及支原体，同时最大限度保留生长因子、细胞因子等热敏性活性成分，避免热灭活引起的营养损失和蛋白变性。 基于上述质控体系，本品兼具高安全性、高活性和高批间一致性，特别适用于生物制药生产、疫苗制备、细胞治疗研究，以及对热灭活敏感的细胞培养实验（如原代细胞、干细胞等）。同时，也可为常规细胞培养提供额外的病毒安全保障，是兼顾法规合规性与实验性能的理想选择。
本品采用钴-60 放射源γ 射线低温辐照灭活工艺，依据《T/CSNAS 04—2023 牛血清γ射线辐照灭活工艺规范》执行标准化生产。高能γ 光子通过双重机制清除血清内源病原。
实施辐照所用的辐照装置： SQ(H)- 630 型(1#) 辐照装置
检测方法：GB/T 15053-2008 使用辐射显色薄膜和聚甲基丙烯酸甲酯剂量测量系统测量吸收剂量的标准方法。
关键工艺质控标准
1.辐照目标剂量：30～35 kGy，单瓶最小吸收剂量≥30 kGy，最大不超40 kGy；
2.辐照全程血清温度：≤-18℃；
3.剂量均匀度：Dmax/Dmin ≤1.3；
4.灭活效果：支原体阴性。
5.理化指标
检测项目 | 方法 | 合格标准 | 激素残留量 | ELISA | ≤1nmol/ml | 内毒素 | 鲎试剂法（LAL） | ≤10 EU/mL | 无菌性 | 膜过滤法 | 无菌生长（14 天培养） | 支原体 | PCR 法/培养法 | 阴性 | 病毒检测（BVDV） | PCR/细胞培养法 | 阴性 | 蛋白质含量 | 双缩脲法/BCA | 20～50 g/L | 渗透压 | 冰点渗透压计 | 250～330mOsmol/kg |
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使用建议
γ辐照血清经过低温冻态辐照处理，蛋白体系更稳定，但不当融化易造成微量蛋白析出，影响培养效果，建议严格遵循梯度融化规范：
1. 标准融化流程：先置于4℃冰箱缓慢过夜解冻，期间每2–3 小时轻柔颠倒混匀，保证血清组分均匀，避免底部蛋白浓度富集；完全解冻后再放入37℃水浴快速复温，即刻取出使用。
2. 禁止操作：严禁室温直接解冻、开水快速解冻、反复冻融，高温及温差过大会导致辐照后敏感活性蛋白变性、产生絮状沉淀，降低细胞促生长性能。
3. 沉淀处理：γ辐照血清解冻后出现极微量细微蛋白颗粒为正常物理现象，属于辐照后可逆蛋白析出，无需过滤、不影响细胞培养与实验结果；若出现大量结块浑浊，禁止使用。
4.细胞培养体系配比适配：常规哺乳动物细胞、干细胞、病毒包装细胞推荐标准配比：基础培养基+10% γ照射特级胎牛血清；原代细胞、脆弱细胞可根据长势微调至10%–15%浓度，保障细胞活性。
5.体系适配性：本品无补体灭活缺陷、无菌无病毒污染，无需二次热灭活、无需二次过滤灭菌，可直接配制培养基使用，二次热处理会损耗生长因子活性、降低培养性能。
6. 换液与传代建议：高精密实验、病毒包装、干细胞扩增实验中，建议缩短换液周期，维持体系洁净稳定，最大化发挥本品低污染、高活性的优势；批次更换时无需细胞驯化，本品批次一致性高，可直接替换使用。
本产品仅用于科研或工业用途，不适用于临床治疗。
用户需根据自身实验体系验证血清适用性，生产方不承担因操作不当导致的实验结果偏差责任。
Fetal bovine serum (FBS) is a core natural nutrient supplement in cell culture systems. It is rich in growth factors, adhesion proteins, amino acids, trace elements, and various bioactive regulatory factors essential for cell growth, proliferation, and attachment, effectively maintaining normal cellular metabolism and physiological status of cells in vitro. Gamma-irradiated fetal bovine serum is a high-quality serum product terminally sterilized by controlled-dose high-energy gamma irradiation under low-temperature conditions (maintained at ≤−18°C throughout the entire process). Its key advantages include: efficient inactivation of viruses and mycoplasma without the need for heat treatment, while maximally preserving heat-labile bioactive components such as growth factors and cytokines, thereby avoiding nutrient loss and protein denaturation caused by heat inactivation.
Based on the above quality control system, this product combines high safety, high bioactivity, and high batch-to-batch consistency. It is particularly suitable for biopharmaceutical production, vaccine preparation, cell therapy research, and cell culture experiments sensitive to heat inactivation (e.g., primary cells, stem cells, etc.). At the same time, it can provide an additional viral safety barrier for routine cell culture, making it an ideal choice that balances regulatory compliance and experimental performance.
This product employs a cobalt-60 gamma-ray low-temperature irradiation inactivation process, and production is standardized according to the T/CSNAS 04—2023 Technical Specification for Gamma-Ray Irradiation Inactivation of Bovine Serum. High-energy gamma photons eliminate endogenous pathogens in serum through a dual mechanism.
Irradiation facility used: SQ(H)-630 (Unit #1) irradiation facility
Detection method: GB/T 15053-2008 Standard Method for Measuring Absorbed Dose Using Radiochromic Film and Polymethylmethacrylate (PMMA) Dosimetry Systems
Key Process Quality Control Standards
1.Target irradiation dose: 30–35 kGy; minimum absorbed dose per bottle ≥30 kGy, maximum ≤40 kGy.
2.Serum temperature throughout irradiation: ≤−18°C.
3.Dose uniformity: Dmax/Dmin ≤1.3.
4.Inactivation efficacy: Mycoplasma negative.
5.Physicochemical specifications
Test Item | Method | Acceptance Criteria | Endotoxin | LAL (Limulus Amebocyte Lysate) | ≤10 EU/mL | Sterility | Membrane filtration | No growth (14day culture) | Mycoplasma | PCR / culture method | Negative | Virus (BVDV) | PCR / cell culture method | Negative | Protein content | Biuret / BCA method | 20–50 g/L | Osmolality | Freezingpoint osmometer | 250–330 mOsmol/kg |
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Usage Recommendations
Gamma-irradiated serum is processed under frozen-state low-temperature irradiation, which renders the protein system more stable. However, improper thawing may cause minor protein precipitation and affect culture performance. It is recommended to strictly follow a gradient thawing protocol:
1.Standard thawing procedure: First place at 4°C in a refrigerator for slow overnight thawing. During this period, gently invert and mix every 2–3 hours to ensure uniform serum components and avoid protein concentration at the bottom. After complete thawing, place in a 37°C water bath for rapid rewarming and remove for immediate use.
2.Prohibited operations: Do not thaw directly at room temperature, do not use hot water for rapid thawing, and do not subject to repeated freeze-thaw cycles. High temperatures and large temperature fluctuations can cause denaturation of sensitive active proteins after irradiation and produce flocculent precipitates, reducing cell growth-promoting performance.
3.Precipitate handling: The appearance of extremely minor fine protein particles after thawing of gamma-irradiated serum is a normal physical phenomenon, representing reversible protein precipitation after irradiation. No filtration is required, and it does not affect cell culture or experimental results. If substantial agglomeration or turbidity occurs, do not use.
4.Cell culture system ratio adaptation: For routine mammalian cells, stem cells, and virus packaging cells, the recommended standard ratio is basal medium + 10% gamma-irradiated premium fetal bovine serum. For primary cells and delicate cells, the concentration may be adjusted to 10%–15% based on growth conditions to ensure cell viability.
5.System compatibility: This product has no complement inactivation defects and is sterile and virus-free. No secondary heat inactivation or secondary filter sterilization is required; it can be used directly to prepare culture media. Secondary heat treatment will deplete growth factor activity and reduce culture performance.
6.Medium change and subculture recommendations: In high-precision experiments, virus packaging, and stem cell expansion, it is recommended to shorten the medium change interval to maintain a clean and stable system, maximizing the low-contamination and high-activity advantages of this product. When switching batches, no cell acclimation is required due to high batch-to-batch consistency; the product can be used directly as a replacement.
Intended Use and Disclaimer
This product is intended for research or industrial use only; it is not indicated for clinical treatment. Users are responsible for validating the suitability of the serum in their own experimental systems. The manufacturer assumes no liability for deviations in experimental results arising from improper handling or operation.
ZJ26F0938976
危险品化学品经营许可证（带存储）