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GMPグレードのサイトカイン製品

GMP Grade Cytokines
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CAR-T \ NKを初めとする免疫細胞治療は、白血病、リンパ腫、多発性骨髄腫など、様々な悪性腫瘍の治療に著しい治療効果を示しており、世界中から注目を集めています。現在では、数多い細胞治療薬がFDAによって承認されています。免疫細胞療法が臨床試験や販売申請に進むと、製品の品質や製造管理に関する規制が必要となります。免疫細胞治療製品の製造工程において、IL-15、IL-7、IL-21などの培地サプリメントがT \ NK免疫細胞の増殖と分化の主な試薬であり、免疫細胞治療薬の製造の主要な原料です。このように、免疫細胞治療薬の開発・販売を成功させるためには、安全で効果的かつ規制を満たすサイトカインが不可欠です。
弊社ACROBiosystemsは、免疫細胞治療薬の臨床応用で使用できる高品質の試薬の開発に取り組んでおります。さらに、生産体制としては、GMPグレードの品質管理システムプラットフォームを利用し、細胞治療薬の製造規制と厳格な品質管理基準に従い、合格した製品だけを市場に送り出しております。弊社はIL-15、IL-7、IL-21など、様々な高品質のGMPグレードサイトカインの開発に成功しております。免疫細胞治療薬の臨床研究をサポートし、医薬品規制当局の承認を加速できます。
*弊社のGMPグレードの製品は、研究開発、製造、またはin vitroでの使用を目的としておりますが、人間に直接使用することはできません。

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ACROBiosystemsの GMPグレード製品の生産体制
GMPグレード品質管理システム

ISO 9001:2015とISO 13485:2016認証取得

いずれの工場でも医薬品製造承認を取得

医薬品B+Aレベルのクリーンルームと自動充填装置

無菌操作と二次滅菌ろ過

動物由来成分フリー

スタッフに厳しいトレーニングを実施

サプライヤーと原材料の管理

QA基準を満たす品質/製造過程

全ての工程を記録し、監視されています

機器のメンテナンスと校正を定期的に実施

分析法は検証済み

Regulatory Support Files (RSF) を提供可能

Click here to applicate the
Regulatory Support File (RSF)
全自動充填装置
Automatic filling equipment
滅菌装置
terilization equipment
品質管理を厳格に実施
(IL-15を例とする)

生物活性>0.8 x 107 1U/mg

純度>95%

エンドトキシン<10EU/mg

残留宿主細胞のDNA含有量は0.02ng/μg未満

残留宿主細胞タンパク質含有量は0.5ng/ug未満

無菌試験

マイコプラズマの検出

外因性ウイルスの検出

ロット間の一貫性は良好

高い安定性が確認されています (加速試験、凍結融解試験、長期保存試験、輸送期間の安定性)

特長

厳格な品質管理基準 

- 16条の品質管理基準を実施.

- 高い安全性(無菌、マイコプラズマ、外来ウイルス、各種不純物の残留検査).

- ロット間の一貫性は良好である.

GMPグレードの品質管理システム

- ISO5レベルのクリーンルーム.

- 原材料から梱包材まで厳格な品質管理体制を構築.

- オンライン/オフラインから監査できます.

生物学的製剤の規制当局の承認を加速

- 細胞/遺伝子治療用製品のための包括的な規制文書が利用可能です.

- 方法論的検証レポートを提供.

- FDA DMF ファイリング済み.

製品一覧
分子名製品コード説明注文/事前注文
IL-15GMP-L15H13GMP Human IL-15

注文

IL-7GMP-L07H24GMP Human IL-7

注文

IL-21GMP-L21H25GMP Human IL-21

事前注文

その他 GMP 製品
分子名製品コード説明注文/事前注文
CD3GMP-MC0323GMP Monoclonal Anti-Human CD3 Antibody (OKT3) DMF Filed

注文

BenzNucleaseGMP-NUES19GMP GENIUS™ Nuclease

事前注文

Cas9GMP-CA9S19GMP NLS-Cas9 Nuclease

事前注文

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アッセイデータ

高純度

High purity than 90% of GMP Human IL-15

SDS-PAGE純度>95%

高い生物活性

BCMA

GMP Human IL-15 (Cat. No. GMP-L15H13) stimulates the proliferation of CTLL-2 cells. The EC50 for this effect is 1.004 ng/mL, corresponding to a specific activity of > 0.8ⅹ10^7 IU/mg, which is calibrated against human IL- 15 WHO International Standard (NIBSC code: 95/554).

高い安定性

加速試験と凍結融解試験における安定性の検証
GMP-L15H13

GMP Human IL-15 (GMP-L15H13) is stable in undiluted samples at 25℃ for 72 hours and freeze-thaw 3 times without performance reduction.

長期保存試験(4℃)
GMP-L15H13

GMP Human IL-15 (GMP-L15H13) is stable in undiluted samples at 25 ℃ for 90 days without performance reduction performance reduction.

ロット間の一貫性は良好

GMP-L15H13

Bioactivity of three different lots of GMP Human IL-15 (GMP-L15H13) verified by cell-based assay, and the result shows very high batch-to-batch consistency.

説明

MANUFACTURING SPECIFICATIONS

MANUFACTURING SPECIFICATIONS

ACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: 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 Quality Management System Contents:

  1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.

  2. Animal-Free materials

  3. Materials purchased from the approved suppliers by QA

  4. ISO 5 clean rooms and automatic filling equipment

  5. Qualified personnel

  6. Quality-related documents review and approve by QA

  7. Fully batch production and control records

  8. Equipment maintenance and calibration

  9. Validation of analytical procedures

  10. Stability studies conducted

  11. Comprehensive regulatory support files


ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:

  1. SDS-PAGE

  2. Protein content

  3. Endotoxin level

  4. Residual Host Cell DNA content

  5. Residual Host Cell Protein content

  6. Biological activity analysis (Reference the WHO Human IL-15 (NIBSC code: 90/530) as standard)

  7. Microbial testing

  8. Mycoplasma testing

  9. In vitro virus assay

  10. Residual moisture

  11. Batch-to-batch consistency


DISCLAIMER

ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.

TERMS AND CONDITIONS

TERMS AND CONDITIONS

All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.


ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS.  IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCAHSE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS.  IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

END USER TERMS OF USE OF PRODUCT

The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product.  If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to  in their territory.

ほかの細胞治療について

リファレンス

  • [1] Libby, Kendra A, and Xiaolei Su. Imaging Chimeric Antigen Receptor (CAR) Activation[J]. Methods in molecular biology. 2020, 153-160.

  • [2] Chinese Pharmacopoeia

  • [3] Corrected Draft Guidance for Industry: Chemistry, Manufacturing,and Control(CMC) Information for Human Gene Therapy Investigation New Durg Applications(INDs). FDA, CBER, 2018.7.20

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