MDCK-33016，MDCK-33016PF BioVector® cell line犬肾脏上皮细胞-流感病毒疫苗生产用细胞株

BioVector® MDCK-33016 Cell Line Datasheet

English Version

1. Cell Line Overview

• Cell Line Name: BioVector® MDCK-33016 (also referred to as MDCK-33016PF)

• Species of Origin:Canis familiaris (Canine)

• Tissue Origin: Kidney

• Cell Type: Epithelial

• Morphology: Adherent; can be adapted for suspension growth in serum-free media

• Parental Line: Derived from the original MDCK (Madin-Darby Canine Kidney) cell line

• Deposit Institution: DSM ACC 2219

2. Description and Applications
BioVector® MDCK-33016 is a qualified continuous cell line specifically developed and selected for its high susceptibility to influenza viruses. It is a key substrate for the production of cell-based seasonal and pandemic influenza vaccines, such as the commercial vaccine BioVector® Optaflu®. The cell line supports efficient isolation and propagation of human influenza A and B viruses, often demonstrating higher isolation rates and better antigenic match to circulating strains compared to traditional egg-based methods.

3. Key Features

• High Virus Yield: Engineered to support robust replication of influenza viruses.

• Vaccine Production: Used in the manufacture of cell culture-derived influenza vaccines.

• Regulatory Acceptance: Qualified and validated for use in human vaccine production.

• Safety: Multiple, orthogonal purification processes ensure the removal of residual cells and DNA, reducing theoretical risks to effectively zero.

4. Growth and Culture Conditions

• Recommended Medium: BioVector® High Salt LB-Miller Medium (for related bacterial work) or specifically formulated serum-free media optimized for BioVector® MDCK-33016 cells. Note that these cells require 1% NaCl and specific formulations for optimal growth.

• Growth Characteristics: Cells grow at a controlled rate suitable for vaccine production. Adherent cultures require standard incubation conditions (37°C, 5% CO₂).

• Suspension Adaptation: The cell line can be adapted to grow in suspension using appropriate serum-free media, facilitating large-scale bioreactor production.

5. Quality Control and Safety

• Sterility Testing: Negative for bacteria, fungi, and mycoplasma.

• Viral Testing: Extensively tested and confirmed negative for adventitious viral agents and oncogenic viruses.

• Tumorigenicity: Like most continuous cell lines, it can form tumors in immunocompromised mice, necessitating rigorous purification of final products.

6. Applications

• Isolation and propagation of influenza viruses from clinical specimens

• Production of cell culture-derived influenza vaccines (seasonal and pandemic)

• Development of candidate vaccine viruses (CVVs)

• Reverse genetics systems for influenza virus rescue

• Virology research and diagnostic assays

BioVector® MDCK-33016 细胞系

中文版本

1. 细胞系概述

• 细胞系名称： BioVector® MDCK-33016（也称为 MDCK-33016PF）

• 物种来源： 犬 (Canis familiaris)

• 组织来源： 肾脏

• 细胞类型： 上皮细胞

• 形态特征： 贴壁生长；可适应在无血清培养基中悬浮培养

• 亲本系： 源自原始的 MDCK（马-达二氏犬肾）细胞系

• 保藏机构： BioVector® ACC2219

2. 描述与应用
BioVector® MDCK-33016 是一种经认证的连续细胞系，专门开发并筛选用于其对流感病毒的高敏感性。它是生产基于细胞的季节性和大流行性流感疫苗（例如商业疫苗 BioVector® Optaflu®）的关键底物。该细胞系支持人甲型和乙型流感病毒的高效分离和扩增，与传统的鸡胚方法相比，通常表现出更高的分离率和与流行株更好的抗原匹配性。

3. 主要特征

• 高病毒产量： 经改造以支持流感病毒的稳健复制。

• 疫苗生产： 用于生产细胞培养衍生的流感疫苗。

• 监管认可： 经过验证，可用于人用疫苗生产。

• 安全性： 多重、正交的纯化工艺确保去除残留细胞和DNA，将理论风险降至实际上为零的水平。

4. 生长与培养条件

• 推荐培养基： BioVector® 高盐 LB-Miller 培养基（用于相关细菌工作）或专为 BioVector® MDCK-33016 细胞优化的特定无血清培养基。请注意，这些细胞需要1%的NaCl和特定的配方以达到最佳生长。

• 生长特性： 细胞以适用于疫苗生产的受控速率生长。贴壁培养需要标准的孵育条件（37°C，5% CO₂）。

• 悬浮驯化： 该细胞系可使用适当的无血清培养基驯化为悬浮生长，便于大规模生物反应器生产。

5. 质量控制与安全性

• 无菌检测： 细菌、真菌和支原体检测均为阴性。

• 病毒检测： 经过广泛检测，确证无异源病毒因子和致癌病毒。

• 致瘤性： 与大多数连续细胞系一样，它可在免疫缺陷小鼠体内形成肿瘤，因此需要对最终产品进行严格的纯化。

6. 应用

• 从临床样本中分离和扩增流感病毒

• 生产细胞培养衍生的流感疫苗（季节性和大流行性）

• 候选疫苗病毒（CVV）的开发

• 用于流感病毒拯救的反向遗传学系统

• 病毒学研究和诊断检测

BioVector NTCC质粒载体菌株细胞蛋白抗体基因保藏中心

电话:400-800-2947

工作QQ/微信同号:1843439339

网址 www.biovector.net