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。常规胎牛血清内含有完整补体系统、异体血清蛋白、热敏性杂蛋白等组分，在免疫细胞实验、干细胞培养、抗体结合实验、细胞吞噬与补体干预试验中，未灭活的补体会引发非特异性免疫反应，造成细胞应激损伤、实验背景偏高、数据误差大等问题。
本品为热灭活工艺专属特级胎牛血清，甄选非疫区健康胎牛新鲜血源，经低温精制、多级除杂、纳米无菌过滤后，采用行业标准化56℃、30 min 精准恒温热灭活工艺处理。可彻底灭活血清内补体活性、破坏热敏性干扰杂质，同时最大程度保留细胞增殖所需核心营养活性。产品无菌等级高、杂质本底低、批次稳定性优异，专门适配对补体敏感的细胞培养与免疫相关功能性实验，是免疫学科研、基础细胞培养实验的优选原料。
产品优势
精准灭活，消除补体干扰：标准化恒温热灭活工艺，彻底失活血清中C1-C9 全套补体组分，杜绝补体介导的细胞裂解、非特异性激活，大幅降低免疫实验背景噪音。
适配敏感细胞与免疫实验：有效减少血清内源热敏性杂质干扰，适配免疫细胞、干细胞、原代细胞等敏感细胞培养，显著提升细胞存活率与实验重复性。
高纯低杂，培养体系洁净：采用多级低温离心、梯度过滤精制工艺，去除血细胞碎片、纤维蛋白、脂蛋白微颗粒，血清澄清度高，冻融后沉淀少。
活性均衡，长势稳定：严格把控热灭活温度与时长，规避过度加热导致的核心生长因子变性、蛋白降解，兼顾补体灭活效果与细胞促生长性能。
全维度安全质控：全程无菌冷链生产，无化学添加剂，经多重微生物、病毒、理化指标筛查，无外源污染，适配各类基础科研与机制研究。
生产工艺简介
本品采用源头优选低温精制+精准热灭活+多级无菌过滤+批次功能验证全套标准化生产工艺，全程C 级洁净区、A 级无菌灌装，核心工序如下：
源头血源筛选：严格选用非疫区健康胎牛，无菌密闭心脏穿刺采血，全程低温冷链保存，严控溶血率与初始杂质，剔除高内毒素、高杂质不合格血源，从源头保障血清基础品质。
低温粗制澄清：4℃低温静置凝血，多级梯度低速、高速离心处理，彻底去除血细胞、纤维蛋白沉淀、脂质微粒及细胞碎片，降低血清杂蛋白本底。
精准恒温热灭活（核心工序）：采用水浴均匀升温方式，精准控温56℃、恒温30 分钟，全程温度波动≤±1℃，确保补体完全灭活，同时最大限度保护生长因子、黏附蛋白等有效活性组分，避免局部过热导致蛋白变性失效。
多级纳米除菌过滤：热灭活完成后，采用0.45μm 预过滤去除热变性微量蛋白絮状物，再经双层0.22μm 精滤+多层终端无菌过滤，逐级截留细菌、真菌、支原体等微生物，实现高纯无菌标准。
低温锁活与批次放行：过滤合格后快速降温、无菌分装，-20℃速冻锁存，抑制蛋白氧化降解；每批次均开展细胞培养功能性验证，确认灭活效果与培养性能达标后方可上市。
质量控制指标
1. 物理外观指标
本品为淡黄色至浅琥珀色澄清透明液体，无浑浊、无肉眼可见杂质、无大型絮状团块；热灭活后允许存在极微量可逆性蛋白析出，37℃水浴充分混匀后可完全溶解，无持续性沉淀、无分层现象。
2. 理化指标
pH 值（25℃）：7.0–8.5
总蛋白含量：20–50 g/L
血红蛋白：≤200 mg/L，低溶血本底，减少细胞氧化应激损伤
内毒素：≤10 EU/mL，低热原，适配敏感细胞培养
渗透压：250–330 mOsm/kg，适配多数哺乳动物细胞培养体系
3. 微生物安全指标
无菌检查：需氧菌、厌氧菌、真菌培养全部阴性
支原体：PCR 分子检测+培养法双重验证，结果阴性
噬菌体：噬斑法检测阴性，无隐性细胞裂解污染源
牛源病毒筛查：牛病毒性腹泻病毒（BVDV）、副流感3 型（PI3）、蓝舌病病毒等全部阴性
4. 工艺专属功能指标
补体活性：56℃ 30min 热灭活后，血清补体活性完全丧失，无补体介导的细胞损伤与非特异性免疫激活
细胞适配性：可稳定支撑HeLa、Vero、RAW264.7、原代细胞、干细胞等多类细胞正常贴壁、增殖，细胞形态规整、活率稳定
批次稳定性：批次间细胞增殖速率、培养状态无显著差异，免疫实验背景值均匀，重复性良好
适用范围
本品适配所有需要消除补体干扰的细胞培养与免疫相关实验，核心适用场景：免疫细胞（巨噬细胞、T 细胞、B 细胞）培养、细胞免疫功能检测、补体相关机制研究、干细胞培养、原代细胞分离培养、抗体结合实验、细胞吞噬实验、普通肿瘤细胞与常规哺乳动物细胞传代培养；是免疫学研究、基础细胞生物学实验的专用血清。
不适用场景：对热敏感的特殊细胞培养、需保留完整补体活性的功能性实验、超高活性生长因子依赖的精密组学实验。
使用方法
血清融化：-20℃冻存血清先置于4℃冰箱缓慢过夜解冻，期间轻柔颠倒混匀，避免局部浓度不均；完全解冻后37℃水浴复温备用，严禁快速高温解冻。
培养基配制：常规细胞培养推荐配比：基础培养基（DMEM/RPMI 1640 等）+ 10%本品热灭活胎牛血清，可根据实验需求选择性添加1%青霉素-链霉素双抗。
标准培养条件：常规哺乳动物细胞置于37℃、5% CO₂ 、饱和湿度恒温培养箱中培养，根据细胞生长状态定期换液、传代。
使用说明：本品已完成标准化热灭活工艺，无需用户二次加热灭活，避免过度热处理导致营养活性流失、蛋白大量析出。
注意事项
热灭活工艺处理后，血清出现微量细小蛋白沉淀为正常热变性现象，不影响细胞培养效果与实
验数据，无需过滤处理。
请勿与未灭活血清、低等级非标血清混用，避免引入活性补体及外源杂质，干扰免疫实验结果。
实验操作全程严格遵守无菌操作规范，开封后尽快使用，防止人为微生物污染。
本品批次稳定性优异，常规实验无需批次驯化，可直接替换不同批次产品使用。
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 metabolism and physiological status of cells in vitro. Conventional FBS contains an intact complement system, xenogeneic serum proteins, and heat‑labile contaminating proteins. In immunological experiments, stem cell culture, antibody binding assays, phagocytosis studies, and complement intervention tests, non‑inactivated complement can trigger nonspecific immune responses, leading to cell stress damage, high experimental background, and significant data deviation.
This product is a premium fetal bovine serum specifically processed by heat inactivation. It is sourced from healthy fetuses in disease‑free regions, collected as fresh blood, and subjected to low‑temperature refining, multi‑stage impurity removal, and nanofiltration sterilization, followed by a standardized heat inactivation process at 56°C for exactly 30 minutes. This treatment completely inactivates complement activity and destroys heat‑labile interfering impurities while maximally preserving the core nutritional activities required for cell proliferation. The serum features high sterility, low background impurities, and excellent batch‑to‑batch stability. It is specifically designed for complement‑sensitive cell cultures and immune‑related functional assays, making it the preferred raw material for immunological research and basic cell culture experiments.
Product Advantages
Precise inactivation, eliminating complement interference: The standardized heat inactivation process completely inactivates all complement components (C1–C9) in the serum, preventing complement‑mediated cell lysis and nonspecific activation, significantly reducing background noise in immunological experiments.
Suitable for sensitive cells and immune assays: Effectively reduces interference from endogenous heat‑labile impurities, making it suitable for sensitive cell types such as immune cells, stem cells, and primary cells, markedly improving cell viability and experimental reproducibility.
High purity, low impurities, clean culture environment: Multi‑stage low‑temperature centrifugation and gradient filtration remove blood cell debris, fibrin, and lipoprotein microparticles, resulting in high serum clarity and minimal precipitate after freeze‑thaw cycles.
Balanced activity, stable growth: Strict control over inactivation temperature and duration prevents overheating that could denature core growth factors or degrade proteins, achieving a balance between complement inactivation and cell‑growth support.
Comprehensive quality control: Produced under a complete cold‑chain aseptic process with no chemical additives; subjected to multiple screenings for microorganisms, viruses, and physicochemical parameters; free from exogenous contaminants, suitable for various basic research and mechanistic studies.
Production Process Overview
This product is manufactured using a full standardized production process including: source selection, low‑temperature refining, precise heat inactivation, multi‑stage sterile filtration, and batch functional validation. All operations are performed in a Grade C clean area with Grade A sterile filling. The key steps are as follows:
Source blood screening: Strict selection of healthy fetuses from disease‑free regions; aseptic closed cardiac puncture blood collection; entire cold‑chain transport at low temperature; strict control of hemolysis and initial impurities; rejection of batches with high endotoxin or high impurity levels to ensure quality from the source.
Low‑temperature crude clarification: Blood is allowed to clot at 4°C, followed by multi‑step low‑speed and high‑speed centrifugation to thoroughly remove blood cells, fibrin precipitates, lipid particles, and cell debris, reducing background serum proteins.
Precise heat inactivation (core step): Using a water bath with uniform heating, the temperature is precisely controlled at 56°C for 30 minutes, with fluctuation ≤ ±1°C, ensuring complete complement inactivation while protecting growth factors, adhesion proteins, and other active components from local overheating and denaturation.
Multi‑stage nanofiltration sterilization: After inactivation, 0.45 μm pre‑filtration removes trace flocculent protein aggregates from heat denaturation, followed by double 0.22 μm fine filtration and multi‑layer terminal sterile filtration to sequentially retain bacteria, fungi, mycoplasma, and other microorganisms, achieving high‑purity sterile standards.
Low‑temperature activity preservation and batch release: After filtration, the serum is rapidly cooled, aseptically aliquoted, and quick‑frozen at –20°C to inhibit protein oxidation and degradation. Each batch undergoes cell culture functional validation to confirm inactivation efficacy and culture performance before release.
Quality Control Specifications
1. Physical Appearance
The product is a clear, transparent liquid ranging from light yellow to light amber, free from turbidity, visible impurities, and large flocculent masses. Trace amounts of reversible protein precipitation may occur after heat inactivation, which completely dissolves upon thorough mixing in a 37°C water bath; no persistent precipitate or stratification is observed.
2. Physicochemical Parameters
pH (25°C): 7.0–8.5
Total protein content: 20–50 g/L
Hemoglobin: ≤200 mg/L (low hemolysis background, reducing oxidative stress damage to cells)
Endotoxin: ≤10 EU/mL (low pyrogen, suitable for sensitive cell culture)
Osmolality: 250–330 mOsm/kg (compatible with most mammalian cell culture systems)
3. Microbiological Safety
Sterility test: Aerobic bacteria, anaerobic bacteria, and fungi cultures: all negative
Mycoplasma: Dual verification by PCR molecular detection and culture method: negative
Bacteriophages: Plaque assay negative; no latent cell‑lysis contamination source
Bovine virus screening: Bovine viral diarrhea virus (BVDV), parainfluenza type 3 (PI3), bluetongue virus, etc.: all negative
4. Process‑Specific Functional Indicators
Complement activity: After heat inactivation at 56°C for 30 min, serum complement activity is completely abolished; no complement‑mediated cell damage or nonspecific immune activation
Cell compatibility: Stably supports normal attachment and proliferation of various cell types including HeLa, Vero, RAW264.7, primary cells, and stem cells, with regular cell morphology and stable viability
Batch‑to‑batch stability: No significant differences in cell proliferation rate or culture status among batches; uniform background values in immunological assays and good reproducibility
Scope of Application
This product is suitable for all cell culture and immune‑related experiments requiring elimination of complement interference. Core applications include: culture of immune cells (macrophages, T cells, B cells); immune function assays; complement‑related mechanistic studies; stem cell culture; primary cell isolation and culture; antibody binding assays; phagocytosis experiments; and routine subculture of tumor cells and common mammalian cells. It is the dedicated serum for immunological research and basic cell biology experiments.
Not recommended for: Special heat‑sensitive cell cultures, functional experiments requiring intact complement activity, or high‑precision omics studies that depend on ultra‑high‑activity growth factors.
Usage Instructions
Thawing: Frozen serum (–20°C) should be thawed slowly at 4°C overnight, with gentle inversion mixing to avoid local concentration gradients. After complete thawing, warm to 37°C in a water bath before use; do not thaw rapidly at high temperatures.
Medium preparation: For routine cell culture, the recommended ratio is basal medium (e.g., DMEM/RPMI 1640) supplemented with 10% of this heat‑inactivated FBS. Optionally add 1% penicillin‑streptomycin as needed.
Standard culture conditions: Maintain mammalian cells at 37°C in a humidified incubator with 5% CO₂; change medium and subculture regularly according to cell growth status.
Important note: This product has already undergone standardized heat inactivation; do not re‑inactivate, as excessive heating may deplete nutritional activity and cause protein precipitation.
Precautions
Trace amounts of fine protein precipitate after heat inactivation are a normal result of heat denaturation and do not affect cell culture performance or experimental data; no filtration is required.
Do not mix with non‑inactivated serum or low‑grade non‑standard serum, as this may introduce active complement and exogenous impurities, interfering with immunological results.
Strict aseptic technique must be followed throughout all operations. Use promptly after opening to prevent microbial contamination.
This product exhibits excellent batch‑to‑batch stability; routine batch adaptation is not required, and different batches can be used interchangeably in standard experiments.
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.
ZJ26F0938977
危险品化学品经营许可证（带存储）