GMP Human FGF-8b 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
FDA DMF filed
Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency
Stringent quality control tests
No animal derived peptone and lactose used in production process
表達(dá)區(qū)間及表達(dá)系統(tǒng)（Source）
GMP Human FGF-8b Protein (GMP-FGBH16) is expressed from E. coli cells. It contains AA Gln 23 - Arg 215 (Accession # P55075-3).
蛋白結(jié)構(gòu)（Molecular Characterization）
This protein carries no "tag".
The protein has a calculated MW of 22.5 kDa. The protein migrates as 25 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE).
N端測(cè)序（N-terminal Sequence Analysis）
Met-Gln-Val-Thr-Val-Gln-Ser-Ser-Pro-Asn-Phe-Thr-Gln-His-Val (Routinely tested).
內(nèi)毒素（Endotoxin）
Less than 10 EU/mg by the LAL method / rFC 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 USP<71>and Ph. Eur. 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.
背景介紹
FGF-8 is a member of the fibroblast growth factor family that was originally discovered as a growth factor essential for the androgen-dependent growth of mouse mammary carcinoma cells (1-3). Alternate splicing of mouse FGF-8 mR generates eight secreted isoforms, designated a-h, but only FGF-8a, b, e and f exist in humans (4). FGF-8 contains a 22 amino acid (aa) signal sequence, an N terminal domain that varies according to the isoform (30 aa for FGF-8b; 20 aa for the shortest, FGF-8a), a 125 aa FGF domain and a 37 aa proline rich C terminal sequence. The FGF domain of FGF-8 shares the most aa identity with FGF17 (75%) and FGF-18 (67%), and the three form an FGF subfamily (2). Mouse FGF-8b shares 100% aa identity with human FGF-8b. FGF-8 is widely expressed during embryogenesis, and mediates epithelial-mesenchymal transitions. It plays an organizing and inducing role during gastrulation, and regulates patterning of the midbrain/hindbrain, eye, ear, limbs and heart in the embryo (2, 5 - 8). The isoforms may play different roles in development. FGF-8b shows the strongest receptor affinity and oncogenic transforming capacity although FGF-8a and FGF-8e are also transforming and have been found in human prostate, breast or ovarian tumors (1, 5, 9-12). FGF-8 shows limited expression in the normal adult, but low levels are found in the reproductive and genitourinary tract, peripheral leukocytes and bone marrow hematopoietic cells (3, 9, 13).
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?、安全性、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。
關(guān)鍵字： GMP FGF-8b;FGF-8b;FGF-8b蛋白;ACRO;百普賽斯;
百普賽斯集團(tuán)ACROBiosystems Group（股票代碼：301080）是成立于2010年的跨國(guó)生物科技公司，是為全球生物醫(yī)藥、健康產(chǎn)業(yè)領(lǐng)域提供關(guān)鍵生物試劑產(chǎn)品及解決方案的行業(yè)平臺(tái)型基石企業(yè)。2021年在創(chuàng)業(yè)板上市。百普賽斯集團(tuán)業(yè)務(wù)遍布全球，橫跨亞洲、北美洲、歐洲，在中國(guó)、美國(guó)、瑞士等12個(gè)城市設(shè)有辦公室、研發(fā)中心及生產(chǎn)基地。目前累計(jì)服務(wù)客戶超6000家，與全球Top 20醫(yī)藥企業(yè)均建立了長(zhǎng)期、穩(wěn)定的合作伙伴關(guān)系。集團(tuán)旗下?lián)碛衅放艫CROBiosystems百普賽斯、bioSeedin柏思薈、Condense Capital墾拓資本和ACRODiagnostics百斯醫(yī)學(xué)等。