是否无菌：是
细胞融合技术是单克隆抗体制备、杂交瘤细胞构建、细胞杂交育种、免疫工程研究的核心关键技术。融合过程中，细胞经PEG、电融合等外力处理后，细胞膜受损、细胞活力大幅下降、极易出现凋亡、裂解与不增殖状态，对培养环境营养完整性、渗透压稳定性、杂质洁净度、细胞修复活性要求极高。
本品为细胞融合实验专属定制特级胎牛血清，针对细胞融合、杂交瘤筛选、单克隆扩增的特殊培养痛点定向优化生产工艺。通过优选高活性血源、低温精细化除杂、补体调控处理、稳定因子富集、低毒素精制工艺，在大幅降低干扰杂质的同时，高比例保留细胞修复、贴壁、克隆增殖所需的核心活性组分。产品可显著提升融合后细胞存活率、提高杂交瘤克隆形成数量、稳定细胞株抗体分泌能力，是杂交瘤构建、细胞融合筛选、单抗制备体系的专用高端培养原料。
产品优势
1. 显著提升融合细胞存活率：富集细胞修复、膜修复相关活性因子，有效缓解PEG 融合、电融合造成的细胞膜损伤，降低细胞裂解与凋亡比例，大幅提升融合后细胞存活基数。
2. 高克隆形成率、筛选更稳定：优化生长因子与黏附因子配比，支持单细胞、低密度细胞增殖，显著提升杂交瘤细胞单克隆形成效率，解决融合后“长不出、长不快、长势弱”等难题。
3. 低干扰、适配筛选体系：严控内毒素、残余补体、脂蛋白与微颗粒杂质，降低细胞应激与非特异性激活，适配HAT/HT 筛选体系，减少筛选期细胞批量死亡问题。
4. 抗体表达稳定性强：营养体系均衡稳定，可维持杂交瘤细胞长期稳定增殖与分泌功能，保障单抗表达量稳定、批次实验重复性高。
5. 专属功能筛选放行：每批次均经过SP2/0、NS0 等骨髓瘤细胞及融合体系功能验证，杜绝批次差异导致的融合效率波动，适配科研及小规模中试单抗制备。
生产工艺简介
本品采用高活性血源优选、低温多级精制、低干扰纯化、精准补体调控、无菌纳米过滤、融合体系专属验证全套定制化工艺，C 级洁净区生产、A 级无菌灌装，核心
工序如下：
1. 源头高活性血源筛选：甄选非疫区健康胎牛血源，无菌密闭采血、全程低温冷链锁活，优先筛选生长因子丰度高、溶血极低、内毒素本底极低的优质原料，从源头保障细胞修复与增殖活性。
2. 多级低温澄清除杂：采用梯度低温高速离心工艺，分层彻底去除血细胞碎片、纤维蛋白、粗大脂蛋白颗粒与变性杂蛋白，大幅降低培养体系沉淀与杂质干扰，适配低密度、高敏感融合细胞培养。
3. 补体调控钝化工艺：采用温和热处理结合吸附纯化工艺，可控钝化残余补体与热敏性干扰蛋白，消除补体介导的细胞损伤，同时完整保留细胞增殖、膜修复所需关键活性组分，区别于普通全热灭活血清的活性损耗问题。
4. 纳米无菌过滤：采用0.1μm 终端除菌过滤体系，逐级截留细菌、真菌、支原体及微量微粒，实现高纯无菌、低杂质体系。
5. 细胞融合专属功能验证：每批次成品必须经过骨髓瘤细胞培养、细胞融合效率测试、单克隆形成率验证、HAT 筛选适应性测试，各项指标达标后方可批次放行。
质量控制指标
1. 性状
澄清稍粘稠的液体，无溶血或异物，冻融后可能存在少量絮状沉淀。
2. 理化指标
pH 值（25℃）：7.00～8.50
总蛋白：20～50 g/L
血红蛋白：＜200 mg/L
内毒素： ≤10 EU/mL
渗透压：250～330 mOsm/kg
3. 微生物安全指标
无菌检查：无菌生长
支原体：无支原体生长
噬菌体：无噬菌体生长
牛源病毒：牛腹泻病毒、牛腺病毒、牛细小病毒、呼肠孤病毒3 型、狂犬病毒、牛副流感病毒3
型，以上病毒荧光抗体检测均应为阴性，应无细胞病变，血吸附应为阴性。
4. 细胞融合专属功能指标
骨髓瘤细胞适配性：SP2/0、NS0 细胞长势旺盛、形态圆润、活率≥95%
融合后细胞存活率：PEG 融合后细胞存活比例显著优于普通特级血清
单克隆形成能力：低密度培养克隆形成率高、克隆团饱满、增殖速度均匀
筛选体系适配性：兼容HAT、HT 筛选培养，筛选期细胞无大面积死亡、长势稳定
长期培养稳定性：杂交瘤细胞连续传代稳定，抗体分泌状态均匀、无明显衰减
适用范围
专用于细胞融合与单克隆抗体制备体系，核心适用场景：SP2/0、NS0 骨髓瘤细胞培养、淋巴细胞-骨髓瘤细胞融合、杂交瘤细胞构建与筛选、HAT/HT 选择性培养、单克隆细胞株驯化与扩增、杂交瘤细胞抗体分泌培养、细胞杂交实验、免疫细胞共培养等高精度、高灵敏度细胞筛选实验。
不适用场景：去外泌体科研实验、超高精度组学分析、特殊热敏细胞专项培养。
使用方法
血清融化：-20℃冻存血清置于4℃冰箱缓慢过夜解冻，期间轻柔颠倒混匀，保证组分均匀；完全解冻后37℃水浴复温即可使用，禁止快速高温解冻与反复冻融。
常规培养配制：RPMI 1640 基础培养基+ 10%本品胎牛血清，可根据实验需求添加双抗。融合及筛选期配制：融合后复苏、筛选阶段建议维持10%血清浓度，保障受损细胞修复与克隆生长，提升建株成功率。
培养条件：37℃、5% CO₂ 、饱和湿度培养箱常规培养，根据杂交瘤生长状态及时换液、筛选与亚克隆。
注意事项
本品仅用于体外细胞科研实验，禁止用于人体临床、活体注射及相关医用用途。
血清解冻后微量蛋白析出为正常现象，不影响细胞修复、融合增殖与单抗筛选效果，无需过滤。
融合、筛选关键阶段建议专一使用本品，不随意更换普通血清，避免体系波动导致克隆死亡、建株失败。
全程严格无菌操作，开封后尽快使用，防止人为污染影响筛选结果。
若出现严重浑浊、结块、变色、异味等异常，禁止使用。
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。
Cell fusion technology is a core critical technique in monoclonal antibody preparation, hybridoma cell construction, cell cross-breeding, and immunology engineering research. During the fusion process, after treatment with external forces such as PEG or electrofusion, cell membranes are damaged, cell viability drops significantly, and cells are highly susceptible to apoptosis, lysis, and non-proliferative states. This places extremely high demands on the nutritional integrity, osmotic stability, impurity cleanliness, and cell-repair activity of the culture environment.
This product is a custom‑designed premium fetal bovine serum exclusively for cell fusion experiments, with optimized production processes tailored to address the specific culture challenges of cell fusion, hybridoma screening, and monoclonal expansion. By selecting highly active serum sources, employing low‑temperature fine purification, complement regulation treatment, enrichment of stability factors, and low‑endotoxin refining processes, it substantially reduces interfering impurities while retaining a high proportion of core bioactive components essential for cell repair, attachment, and clonal proliferation. This product significantly improves post‑fusion cell survival, increases the number of hybridoma clones formed, and stabilizes antibody secretion capacity of cell lines. It is a premium specialized culture material for hybridoma construction, cell fusion screening, and monoclonal antibody preparation systems.
Product Advantages
1. Significantly improves post‑fusion cell viability: Enriched with active factors related to cell repair and membrane restoration, effectively alleviating membrane damage caused by PEG‑mediated or electrofusion, reducing cell lysis and apoptosis rates, and substantially increasing the post‑fusion viable cell base.
2. High cloning efficiency and more stable screening: Optimized ratios of growth factors and adhesion factors support single‑cell and low‑density cell proliferation, significantly enhancing hybridoma monoclonal formation efficiency and resolving common issues such as "failure to grow, slow growth, or weak growth" after fusion.
3. Low interference and screening‑system compatibility: Strict control of endotoxins, residual complement, lipoproteins, and microparticulate impurities reduces cellular stress and non‑specific activation. Compatible with HAT/HT selection systems, minimizing batch cell death during the selection period.
4. Stable antibody expression: The balanced and stable nutritional system maintains long‑term proliferation and secretory function of hybridoma cells, ensuring consistent monoclonal antibody expression levels and high batch‑to‑batch experimental reproducibility.
5. Dedicated functional release testing: Each batch is functionally validated using myeloma cell lines such as SP2/0 and NS0, as well as fusion system assays, eliminating batch‑to‑batch variability in fusion efficiency. Suitable for research and small‑scale pilot monoclonal antibody production.
Production Process Overview
This product is manufactured using a full suite of customized processes: selection of highly active serum sources, low‑temperature multistage refining, low‑interference purification, precise complement regulation, sterile nanofiltration, and fusion‑system‑specific validation. Production is carried out in a Grade C clean area with Grade A sterile filling. Core process steps are as follows:
1. Source selection of highly active serum: Sourced from healthy fetal bovine serum from non‑epidemic regions, collected via sterile closed‑system bleeding, and maintained under a complete low‑temperature cold chain to preserve activity. Priority is given to raw materials rich in growth factors, with extremely low hemolysis and minimal baseline endotoxin levels, ensuring cell repair and proliferative activity from the source.
2. Multistage low‑temperature clarification and impurity removal: Gradient low‑temperature high‑speed centrifugation is employed to thoroughly remove blood cell debris, fibrin, coarse lipoprotein particles, and denatured proteins in layers, significantly reducing precipitate and interfering impurities in the culture system, suitable for low‑density, highly sensitive fusion cell culture.
3. Complement regulation and inactivation: A mild heat treatment combined with adsorptive purification is used to controllably inactivate residual complement and heat‑labile interfering proteins, eliminating complement‑mediated cell damage while preserving key active components required for cell proliferation and membrane repair—distinct from the activity loss associated with conventional fully heat‑inactivated sera.
4. Sterile nanofiltration: A 0.1 μm terminal sterilizing filtration system is employed to sequentially remove bacteria, fungi, mycoplasma, and microparticles, achieving a highly pure, sterile, low‑impurity product.
5. Cell‑fusion‑specific functional validation: Each batch must pass myeloma cell culture, cell fusion efficiency testing, monoclonal formation rate validation, and HAT selection adaptability testing before batch release. All quality indicators must meet specified criteria.
Quality Control Specifications
1. Physical Appearance
Clear, slightly viscous liquid; no hemolysis or foreign matter. A small amount of flocculent precipitate may appear after freeze‑thawing.
2. Physicochemical Properties
pH (25°C): 7.00–8.50
Total protein: 20–50 g/L
Hemoglobin: <200 mg/L
Endotoxin: ≤10 EU/mL
Osmolality: 250–330 mOsm/kg
3. Microbiological Safety
Sterility test: No growth
Mycoplasma: No growth
Bacteriophages: No growth
Bovine‑origin viruses: Bovine viral diarrhea virus, bovine adenovirus, bovine parvovirus, reovirus type 3, rabies virus, and bovine parainfluenza virus type 3—all must be negative by fluorescent antibody testing; no cytopathic effect and negative hemadsorption.
4. Cell‑Fusion‑Specific Functional Indicators
Myeloma cell compatibility: SP2/0 and NS0 cells exhibit robust growth, round morphology, and viability ≥95%.
Post‑fusion cell viability: Survival rate after PEG‑mediated fusion is significantly superior to that with ordinary premium sera.
Monoclonal formation capacity: High cloning efficiency under low‑density culture, with compact, well‑formed clones and uniform proliferation rates.
Screening system compatibility: Compatible with HAT and HT selection media; no massive cell death during selection and stable growth.
Long‑term culture stability: Hybridoma cells maintain stable growth over serial passages, with uniform antibody secretion and no significant decline.
Application Scope
Specifically designed for cell fusion and monoclonal antibody preparation systems. Core applications include: SP2/0 and NS0 myeloma cell culture, lymphocyte‑myeloma cell fusion, hybridoma construction and screening, HAT/HT selective culture, monoclonal cell line adaptation and expansion, hybridoma antibody secretion culture, cell cross‑breeding experiments, and high‑precision, high‑sensitivity immune cell co‑culture assays.
Not suitable for: exosome‑depletion research, ultra‑high‑precision omics analyses, or specialized culture of heat‑sensitive cells.
Instructions for Use
Serum thawing: Thaw serum stored at –20°C overnight at 4°C with gentle, intermittent swirling to ensure uniform composition. After complete thawing, warm in a 37°C water bath before use. Avoid rapid high‑temperature thawing and repeated freeze‑thaw cycles.
Routine culture preparation: RPMI 1640 basal medium supplemented with 10% of this serum. Antibiotics may be added as needed. For fusion and selection stages: maintain 10% serum concentration during post‑fusion recovery and selection to support damaged cell repair and clonal growth, enhancing the success rate of cell line establishment.
Culture conditions: Incubate at 37°C in a 5% CO₂ humidified incubator. Perform medium changes, screening, and subcloning according to hybridoma growth status.
Precautions
For in vitro research use only. Not for human clinical application, in vivo injection, or related medical uses.
Trace protein precipitation after thawing is normal and does not affect cell repair, fusion proliferation, or monoclonal screening performance; no filtration is required.
During critical fusion and selection stages, exclusive use of this product is recommended; do not arbitrarily switch to ordinary sera to avoid clone death or failed line establishment due to system fluctuations.
Maintain strict aseptic technique throughout. Use promptly after opening to prevent contamination that could compromise screening results.
Do not use if severe turbidity, clumping, discoloration, or abnormal odor is observed.
Disclaimer
This product is intended for research or industrial use only and is not for clinical therapeutic applications. Users should validate the suitability of the serum for their specific experimental systems. The manufacturer assumes no responsibility for experimental result deviations caused by improper handling or use.
ZJ26F0938973
危险品化学品经营许可证（带存储）