是否无菌：是
本产品BDV（边界病病毒）、BVDV（牛病毒性腹泻病毒）抗原、抗体均为阴性，适用于对病毒安全性要求严格的细胞培养实验。血清中含有丰富的细胞生长必需营养成分，包括各种氨基酸、维生素、无机物、脂类物质，以及胰岛素、多种生长因子（如bFGF、EGF、PDGF）、转铁蛋白等激素与结合蛋白。此外，血清还具有解毒、缓冲pH、抑制蛋白酶活性等保护细胞的功能。
制备原理
原料采集筛选（BDV、BVDV阴性第一道防线）
-选取检疫合格妊娠期胎牛，无菌外科手术剖腹，心脏穿刺无菌采集全血；密闭收集，避免外界微生物污染。
-前置血源筛查：对供血牛源先做BDV、BVDV初筛，剔除可疑带毒、抗体阳性血源，从源头降低BDV、BVDV污染概率，是实现四阴性的基础。
分离（物理离心分离原理）
-利用密度差物理分离血细胞与血清液相，不破坏蛋白、生长因子天然活性。
-全血置于无菌采血袋中常温自然静置凝血（不加抗凝剂），低温低速离心，虹吸吸取上清，弃去血细胞沉淀。
批量混匀均一化处理：将多批次合格粗血清按比例混合均质。原理：稀释单头胎牛个体差异，大幅缩小批次之间理化、生长因子含量差异，保证成品批次稳定性。
梯度深度过滤纯化（除杂、除菌原理）：采用逐级递减孔径封闭式膜过滤，全程低温
-0.65μm预过滤：去除纤维蛋白絮状物、细胞碎屑、大颗粒杂质
-0.22μm除菌过滤：去除细菌、真菌
-0.1μm终级精滤：截留支原体、部分病毒颗粒、微小蛋白聚集体
0.1μm过滤不能完全去除病毒核酸，过滤仅去除颗粒型污染物，BDV、BVDV四阴性不能依靠过滤实现，必须依赖原料筛选+多重检测验证。
不进行工业热灭活，成品生产阶段不做56°C热灭活。原理：高温会破坏多种活性蛋白、补体、多肽因子；仅客户实验需要时，由使用者自行热灭活。
分装、冻存：无菌环境下分装至血清瓶，-20°C快速冷冻储存活性。
BDV、BVDV四阴性实现原理
前置：牧场 + 胎牛个体检疫筛查，排除携带BDV、BVDV母体及胎牛血源
工艺：封闭式采血、生产，避免生产环节交叉引入BVDV
成品阶段四套独立检测验证：
① 细胞病变法：检测活BDV、BVDV病毒
② RT-PCR：检测BDV、BVDV病毒核酸
③ ELISA：检测BDV、BVDV特异性抗体
④ 专用指示细胞盲传检测：检出无细胞病变
BDV、BVDV四阴性不是通过加工把病毒杀掉，而是严格筛选血源，全程防污染，最后四项检测全部验证为阴性。
与普通胎牛血清制备核心区别
普通血清：仅成品检测活病毒（双阴标准），不查核酸、抗体；
四阴性特级血清：血源预筛 + 全套四重专项检测 + 全套外源病毒谱筛查，制备流程一致，质控检测标准显著严于普通血清。
产品优势
病毒安全性极高
四阴性彻底排除了这些干扰源，尤其适合：
-疫苗生产中的病毒种子制备
-干细胞长期培养（避免病毒对多能性的隐性影响）
批次间稳定性强——减少实验变量
-不同批次的促生长活性差异极小
-换批次时无需重新大规模优化培养条件
-长期实验（如连续传代、药物筛选）的数据可重复性显著提高
核心控制指标：病毒检测（BDV、BVDV四阴性重点）
BVDV（牛病毒性腹泻病毒）—阴性，BDV（边界病病毒）—阴性，PI-3（副流感病毒3型）—阴性，IBR（牛传染性鼻气管炎病毒）—阴性，BPV（牛细小病毒）—阴性，蓝舌病病毒、牛腺病毒、狂犬病毒、呼肠孤病毒—阴性
注意事项与常见问题
1.将-10°C以下保存的血清移至4°C冰箱解冻约24小时
2.解冻过程中每隔约2小时轻轻摇晃均匀（避免产生气泡）
3.完全解冻后分装使用，如不能短期内用完，建议解冻后分装保存于-10°C以下，避免反复冻融，分装时瓶内需预留约10%空间（血清结冰体积会增加约10%）
4.切勿直接将血清从冷冻状态放入37°C水浴解冻，温差过大会导致蛋白质凝集和沉淀，影响血清质量
5.血清中的絮状沉淀物（主要是纤维蛋白和脂蛋白变性物）不影响血清质量。如必须去除，可400g离心5分钟，但不建议过滤（絮状物可能阻塞滤膜）
声明
本品为科研试剂，仅供实验室研究使用。不可用于临床诊断、治疗或药物用途。使用者应具备相应的细胞培养知识和实验技能。
This product is negative for both antigens and antibodies of BDV (Border Disease Virus) and BVDV (Bovine Viral Diarrhea Virus), making it suitable for cell culture experiments that demand stringent viral safety. The serum is rich in essential nutrients for cell growth, including various amino acids, vitamins, inorganic substances, lipids, as well as hormones and binding proteins such as insulin, multiple growth factors (e.g., bFGF, EGF, PDGF), and transferrin. In addition, the serum provides protective functions for cells, including detoxification, pH buffering, and inhibition of protease activity.
Preparation Principle
1.Raw Material Collection and Screening (First Line of Defense for BDV/BVDV Negativity)
-Select quarantined and certified pregnant cows, perform aseptic cesarean section, and collect whole blood via sterile cardiac puncture; collect in a closed system to avoid external microbial contamination.
-Pre‑collection blood source screening: Conduct preliminary BDV and BVDV testing on donor cattle, eliminating blood sources that are suspicious for virus or antibody positivity. This reduces the probability of BDV/BVDV contamination at the source and forms the foundation for achieving quadruple negativity.
2.Separation (Physical Centrifugation Principle)
-Utilize density differences to physically separate blood cells from the serum phase, without compromising the natural activity of proteins and growth factors.
-Place whole blood in sterile collection bags, allow natural clotting at room temperature (without anticoagulants), then centrifuge at low temperature and low speed. Aspirate the supernatant by siphon and discard the blood cell pellet.
3.Batch Blending and Homogenization
Mix multiple batches of qualified crude serum in proportion to achieve homogeneity. Principle: Dilute individual fetal bovine differences, significantly reduce batch‑to‑batch variations in physicochemical properties and growth factor content, ensuring stability of the final product across batches.
4.Gradient Depth Filtration and Purification (Impurity and Sterility Removal Principle)
Employ a closed‑system membrane filtration with stepwise decreasing pore sizes, maintained at low temperature throughout:
-0.65 µm pre‑filtration: Removes fibrin flocs, cell debris, and large particulate impurities.
-0.22 µm sterile filtration: Removes bacteria and fungi.
-0.1 µm final polishing filtration: Retains mycoplasma, some viral particles, and small protein aggregates.
Note: 0.1 µm filtration cannot completely remove viral nucleic acids; filtration only removes particulate contaminants. Achieving BDV/BVDV quadruple negativity cannot rely on filtration alone and must be based on raw material screening combined with multiple detection validations.
No Industrial Heat Inactivation
The final production stage does not include heat inactivation at 56°C. Principle: High temperatures can destroy various active proteins, complement, and polypeptide factors. Only when required by the customer's specific experiments should heat inactivation be performed by the user.
Aliquoting and Cryopreservation
Under sterile conditions, aliquot the serum into bottles and rapidly freeze at –20°C to preserve activity.
Principle for Achieving BDV/BVDV Quadruple Negativity
-Pre‑collection: Pasture + individual fetal bovine quarantine screening to exclude maternal and fetal blood sources carrying BDV/BVDV.
-Process: Closed‑system blood collection and production to prevent cross‑introduction of BVDV during manufacturing.
-Four independent validation tests at the final product stage:
① Cytopathic effect assay: Detects live BDV/BVDV virus.
② RT‑PCR: Detects BDV/BVDV viral nucleic acids.
③ ELISA: Detects specific antibodies against BDV/BVDV.
④ Blind passage on specific indicator cells: Confirms absence of cytopathic effect.
BDV/BVDV quadruple negativity is not achieved by killing the virus through processing, but through stringent source screening, full‑process contamination prevention, and final verification by all four tests showing negative results.
Core Differences from Conventional Fetal Bovine Serum Preparation
Conventional serum: Only tests for live virus in the final product (double‑negative standard); does not test for nucleic acids or antibodies.
Quadruple‑negative premium serum: Pre‑screening of blood sources + comprehensive quadruple specific tests + full spectrum of adventitious virus screening. The preparation process is the same, but the quality control testing standards are significantly stricter than those for conventional serum.
Product Advantages
Extremely high viral safety.
Quadruple negativity completely eliminates these interference sources, making it especially suitable for:
Virus seed preparation in vaccine production.
Long‑term stem cell culture (avoiding hidden effects of viruses on pluripotency).
Strong batch‑to‑batch stability – reduces experimental variables:
Minimal differences in growth‑promoting activity between batches.
No need for extensive re‑optimization of culture conditions when switching batches.
Significantly improved data reproducibility in long‑term experiments (e.g., continuous passaging, drug screening).
Core Quality Control Indicators – Virus Detection (Focus on BDV/BVDV Quadruple Negativity)
BVDV (Bovine Viral Diarrhea Virus) – Negative
BDV (Border Disease Virus) – Negative
PI‑3 (Parainfluenza Virus Type 3) – Negative
IBR (Infectious Bovine Rhinotracheitis Virus) – Negative
BPV (Bovine Parvovirus) – Negative
Bluetongue Virus, Bovine Adenovirus, Rabies Virus, Reovirus – Negative
Precautions and Frequently Asked Questions
Move the serum stored at –10°C or below to a 4°C refrigerator for thawing for approximately 24 hours.
During thawing, gently swirl the bottle every 2 hours to mix evenly (avoid creating bubbles).
After complete thawing, aliquot for use. If not used up in the short term, it is recommended to store aliquots at –10°C or below after thawing to avoid repeated freeze‑thaw cycles. Leave about 10% headspace in the aliquot bottle (serum volume increases by about 10% upon freezing).
Do not place the serum directly from the frozen state into a 37°C water bath for thawing; the large temperature difference may cause protein aggregation and precipitation, affecting serum quality.
Flocculent precipitates in the serum (mainly denatured fibrin and lipoproteins) do not affect serum quality. If removal is necessary, centrifuge at 400×g for 5 minutes, but filtration is not recommended (flocculent material may clog the filter membrane).
Disclaimer
This product is intended for research or industrial use only and is not suitable for clinical therapeutic applications. Users are responsible for validating serum suitability in their own experimental systems. The manufacturer assumes no liability for deviations in experimental results arising from improper handling.
ZJ26F0938981
危险品化学品经营许可证（带存储）