GMP Human IL-12 Protein

優(yōu)勢(shì)特色（Features）

Designed under ISO 9001:2015 and ISO 13485:2016

Manufactured and QC tested under a GMP compliance factory

Animal-Free materials

Beta-lactam materials free

Batch-to-batch consistency

Stringent quality control tests

表達(dá)區(qū)間及表達(dá)系統(tǒng)（Source）

GMP Human IL-12 Protein (GMP-L12H23) is expressed from human 293 cells (HEK293). It contains AA Ile 23 - Ser 328 & Arg 23 - Ser 219 (Accession # P29460-1 & P29459-1).

Predicted N-terminus: Ile 23

蛋白結(jié)構(gòu)（Molecular Characterization）

This protein carries no "tag".

The protein has a calculated MW of 58.9 kDa. The protein migrates as 76 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE) due to glycosylation.

內(nèi)毒素（Endotoxin）

Less than 10 EU/mg by the LAL method.

宿主蛋白殘留（Host Cell Protein）

<0.5 ng/μg of protein tested by ELISA.

宿主核酸殘留（Host Cell DNA）

<0.02 ng/μg of protein tested by qPCR.

無(wú)菌（Sterility）

The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.

支原體（Mycoplasma）

Negative.

純度（Purity）

>95% as determined by SDS-PAGE.

制劑（Formulation）

Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.

Contact us for customized product form or formulation.

運(yùn)輸（Shipping）

This product is supplied and shipped with blue ice, please inquire the shipping cost.

存儲(chǔ)（Storage）

Upon receipt, store it immediately at -20°C or lower for long term storage.

Please avoid repeated freeze-thaw cycles.

This product is stable after storage at:

-20°C to -70°C for 5 years in lyophilized state;

-70°C for 12 months under sterile conditions after reconstitution.

ACRO GMP產(chǎn)品制造規(guī)范

ACROBiosystems GMP級(jí)產(chǎn)品是在質(zhì)量管理體系下生產(chǎn)的，并符合相關(guān)指南：

Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing; USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products.

ACROBiosystems質(zhì)量管理體系內(nèi)容：

1. 根據(jù)ISO 9001:2015和ISO 13485:2016進(jìn)行設(shè)計(jì)，在GMP工廠進(jìn)行制造和QC檢測(cè)

2. 無(wú)動(dòng)物成分

3. QA從批準(zhǔn)的供應(yīng)商處采購(gòu)的材料

4. ISO 5潔凈室和自動(dòng)灌裝設(shè)備

5. 人員合格

6. 質(zhì)量保證審核和批準(zhǔn)質(zhì)量相關(guān)文件

7. 全批量生產(chǎn)和控制記錄

8. 設(shè)備維護(hù)和校準(zhǔn)

9. 分析程序的驗(yàn)證

10. 進(jìn)行的穩(wěn)定性研究

11. 全面的法規(guī)支持文件

ACROBiosystems對(duì)我們的GMP級(jí)產(chǎn)品提供嚴(yán)格的質(zhì)量控制測(cè)試（經(jīng)過(guò)充分驗(yàn)證的設(shè)備、工藝和測(cè)試方法），以確保它們?cè)诩兌取踩?、活性和批間穩(wěn)定性方面符合嚴(yán)格的標(biāo)準(zhǔn)，每個(gè)批量QC批次主要包含以下具體信息：

1. SDS-PAGE

2. 蛋白質(zhì)含量

3. 內(nèi)毒素水平

4. 殘留宿主細(xì)胞DNA含量

5. 殘留宿主細(xì)胞蛋白質(zhì)含量

6. 生物活性分析

7. 微生物檢測(cè)

8. 支原體檢測(cè)

9. 體外病毒測(cè)定

10. 殘留水分

11. 批次間一致性

ACRO產(chǎn)品聲明

ACROBiosystems GMP級(jí)產(chǎn)品專為研究、生產(chǎn)或離體使用而設(shè)計(jì)。注意：不可直接供人體使用。

背景（Background）

Interleukin 12 (IL12) is also known as p70, and is an interleukin that is naturally produced by dendritic cells, macrophages and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.IL12 is a heterodimeric cytokine, containing IL-12A (p35) and IL-12B (p40). IL-12 is involved in the differentiation of naive T cells into Th1 cells. It is known as a T cell-stimulating factor, which can stimulate the growth and function of T cells. It stimulates the production of IFN-γ and TNF-α from T cells and NK cells, and reduces IL-4 mediated suppression of IFN-γ. IL-12 plays an important role in the activities of natural killer cells and T lymphocytes. IL-12 also has anti-angiogenic activity, which means it can block the formation of new blood vessels.