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% CO?).

• 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 細(xì)胞系

中文版本

1. 細(xì)胞系概述

• 細(xì)胞系名稱： BioVector? MDCK-33016（也稱為 MDCK-33016PF）

• 物種來源： 犬 (Canis familiaris)

• 組織來源： 腎臟

• 細(xì)胞類型： 上皮細(xì)胞

• 形態(tài)特征： 貼壁生長；可適應(yīng)在無血清培養(yǎng)基中懸浮培養(yǎng)

• 親本系： 源自原始的 MDCK（馬-達(dá)二氏犬腎）細(xì)胞系

• 保藏機(jī)構(gòu)： BioVector? ACC2219

2. 描述與應(yīng)用
BioVector? MDCK-33016 是一種經(jīng)認(rèn)證的連續(xù)細(xì)胞系，專門開發(fā)并篩選用于其對流感病毒的高敏感性。它是生產(chǎn)基于細(xì)胞的季節(jié)性和大流行性流感疫苗（例如商業(yè)疫苗 BioVector? Optaflu?）的關(guān)鍵底物。該細(xì)胞系支持人甲型和乙型流感病毒的高效分離和擴(kuò)增，與傳統(tǒng)的雞胚方法相比，通常表現(xiàn)出更高的分離率和與流行株更好的抗原匹配性。

3. 主要特征

• 高病毒產(chǎn)量： 經(jīng)改造以支持流感病毒的穩(wěn)健復(fù)制。

• 疫苗生產(chǎn)： 用于生產(chǎn)細(xì)胞培養(yǎng)衍生的流感疫苗。

• 監(jiān)管認(rèn)可： 經(jīng)過驗(yàn)證，可用于人用疫苗生產(chǎn)。

• 安全性： 多重、正交的純化工藝確保去除殘留細(xì)胞和DNA，將理論風(fēng)險(xiǎn)降至實(shí)際上為零的水平。

4. 生長與培養(yǎng)條件

• 推薦培養(yǎng)基： BioVector? 高鹽 LB-Miller 培養(yǎng)基（用于相關(guān)細(xì)菌工作）或?qū)?BioVector? MDCK-33016 細(xì)胞優(yōu)化的特定無血清培養(yǎng)基。請注意，這些細(xì)胞需要1%的NaCl和特定的配方以達(dá)到最佳生長。

• 生長特性： 細(xì)胞以適用于疫苗生產(chǎn)的受控速率生長。貼壁培養(yǎng)需要標(biāo)準(zhǔn)的孵育條件（37°C，5% CO?）。

• 懸浮馴化： 該細(xì)胞系可使用適當(dāng)?shù)臒o血清培養(yǎng)基馴化為懸浮生長，便于大規(guī)模生物反應(yīng)器生產(chǎn)。

5. 質(zhì)量控制與安全性

• 無菌檢測： 細(xì)菌、真菌和支原體檢測均為陰性。

• 病毒檢測： 經(jīng)過廣泛檢測，確證無異源病毒因子和致癌病毒。

• 致瘤性： 與大多數(shù)連續(xù)細(xì)胞系一樣，它可在免疫缺陷小鼠體內(nèi)形成腫瘤，因此需要對最終產(chǎn)品進(jìn)行嚴(yán)格的純化。

6. 應(yīng)用

• 從臨床樣本中分離和擴(kuò)增流感病毒

• 生產(chǎn)細(xì)胞培養(yǎng)衍生的流感疫苗（季節(jié)性和大流行性）

• 候選疫苗病毒（CVV）的開發(fā)

• 用于流感病毒拯救的反向遺傳學(xué)系統(tǒng)

• 病毒學(xué)研究和診斷檢測

BioVector NTCC質(zhì)粒載體菌株細(xì)胞蛋白抗體基因保藏中心

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