ART101S Recombinant Human Albumin - Specialized Auxiliary Additive for CGT Industry
In the fast-developing field of Cell and Gene Therapy (CGT), the safety, compliance and functional adaptability of auxiliary materials directly determine the success of therapy development, clinical translation and large-scale production. As a specialized auxiliary additive tailored for the CGT industry, ART101S Recombinant Human Albumin perfectly fits the core needs of cell culture, viral vector production, cell cryopreservation and other key links in CGT, solving the pain points of traditional auxiliary materials such as contamination risks and poor batch consistency, and empowering the high-quality development of the CGT industry with strict compliance and excellent performance.
Compliant and Traceable, Empowering CGT International Declaration. The CGT industry has extremely strict requirements on the quality and compliance of auxiliary materials, which must comply with the cGMP guidelines, ISO 20399:2022 standards, as well as the regulatory requirements of NMPA, FDA and EMA for CGT raw materials[3][5]. ART101S is specially optimized for CGT application scenarios, strictly complying with Tonghua Artet's enterprise standard Q/ART 002-2024, the Chinese Pharmacopoeia 2020 Edition and USP-NF 2023 Edition international standards, and fully meeting the requirements of NMPA's "Good Manufacturing Practice for Pharmaceutical Excipients" implemented in 2026[3]. Each batch of products is accompanied by a complete Certificate of Analysis (COA) report, which can realize full-process traceability from raw material source to production and delivery, effectively meeting the supplier audit and quality traceability needs of CGT enterprises, and helping enterprises shorten the review cycle of IND and NDA applications, and smoothly promote international declaration such as FDA DMF filing[4].
Safe and Pure, Eliminating CGT Core Contamination Risks. For CGT products such as cell therapy and gene therapy, the safety of auxiliary materials is crucial to avoid affecting cell activity and therapeutic effect. ART101S is produced by Pichia pastoris expression system and precise genetic recombination technology, completely free of animal-derived components, blood-derived impurities and blood-borne viruses (such as HIV, HBV), which thoroughly solves the potential safety hazards of traditional plasma-derived human serum albumin (pHSA) and bovine serum albumin (BSA) used in CGT production[2][5]. As a chemically defined, animal-origin-free and blood-free auxiliary additive, it avoids the risks of heterologous immunogenicity and exogenous factor contamination, and is especially suitable for high-safety demand scenarios such as stem cell culture, CAR-T cell amplification and AAV vector production[1][2]. With a purity of ≥99.0% double-verified by SDS-PAGE and Western blotting, and bacterial endotoxin <0.005EU/mg, it ensures that no harmful impurities are introduced into the CGT production process, laying a solid foundation for the safety of CGT products.
Full-Process Adaptation, Supporting CGT Industrialization. ART101S integrates multiple functions and can be widely applied to key links of CGT production, providing all-round support for CGT industrialization[5]: In cell culture, it serves as a high-quality nutritional supplement and stabilizer, which can maintain the undifferentiated state of stem cells, promote the proliferation and survival of CAR-T cells, MSCs and other therapeutic cells, and improve cell viability and amplification efficiency[2][6]; In viral vector production (such as AAV), it can directly interact with AAV capsids, enhance AAV transduction efficiency, increase the expression of therapeutic genes, and effectively improve the therapeutic effect of gene therapy products[1]; In cell cryopreservation, it acts as a non-permeable protectant to stabilize cell membranes, reduce cell apoptosis during cryopreservation and resuscitation, and ensure the activity of therapeutic cells[5]. It is perfectly compatible with CGT production components such as growth factors, cytokines and culture media, and can be flexibly added to different production processes to meet the diverse needs of CGT research and large-scale production.
Stable Supply and Professional Support, Guiding CGT Production Practice. Tonghua Artet, the source of ART101S, is the world's first enterprise to launch recombinant human albumin injection, with a global-leading large-scale production line (annual output up to 50 tons) and mature GMP production system[5]. We strictly control the production process to ensure excellent batch-to-batch consistency of products, avoiding process fluctuations caused by differences in auxiliary materials and ensuring the stability of CGT production[4]. The product is in the form of off-white loose powder or lyophilized powder, easy to dissolve and store, with a 2-year shelf life; cold chain transportation and 2-8℃ sealed storage ensure the stable performance of the additive during transportation and storage, reducing inventory loss[5]. We provide professional technical support tailored for the CGT industry, including recommended addition amount, process adaptation guidance and compliance consulting, to help enterprises optimize production processes and improve production efficiency.
In the era of rapid development of CGT, choosing high-quality auxiliary additives is the key to breaking through industrial bottlenecks and enhancing product competitiveness. ART101S Recombinant Human Albumin, with its compliance, safety and full-process adaptability, has become a reliable partner for CGT enterprises. Whether you are engaged in stem cell therapy, immune cell therapy, gene therapy or other CGT fields, ART101S can perfectly match your production needs, help you solve core pain points, and accelerate the translation of CGT innovative therapies from the laboratory to the clinic!
Product Information:
| Product Namber |
Product Name |
formulation |
Purity |
Specifications |
| ART101S-10g |
Recombinant Human Albumin |
Solid Powder |
＞99% |
10g |
| ART101S-100g |
Recombinant Human Albumin |
Solid Powder |
＞99% |
100g |
| ART101L-10g |
Recombinant Human Albumin |
Liquid Solution |
＞99% |
10g(50ml) |
| ART101L-100g |
Recombinant Human Albumin |
Liquid Solution |
＞99% |
10g(500ml) |
|
ART103S-10g
|
Recombinant Human Albumin |
Solid Powder |
＞99% |
10g |
| ART103S-100g |
Recombinant Human Albumin |
Solid Powder |
＞99% |
100g |
| ART103L-10g |
Recombinant Human Albumin |
Liquid Solution |
＞99% |
10g(50ml) |
| ART103L-100g |
Recombinant Human Albumin |
Liquid Solution |
＞99% |
10g(500ml) |
Important Notice
This product is intended solely for scientific research, laboratory and production purposes. It is not for clinical treatment and shall not be used on animals or humans.
Feel free to contact us
WhatsApp: +85363312841 | Email: sales@bjanrate.cn
Your message must be between 20-3,000 characters!
english
français
Deutsch
Italiano
Русский
Español
português
Nederlandse
ελληνικά
日本語
한국
العربية
हिन्दी
Türkçe
indonesia
tiếng Việt
ไทย
বাংলা
فارسی
polski
