ART101S Recombinant Human Albumin - High-Quality Pharmaceutical Excipient Additive
In the field of pharmaceutical production, the quality of excipient additives directly determines the safety, efficacy and stability of finished drugs. With the implementation of the new National Medical Products Administration (NMPA) guidelines for pharmaceutical excipients, the requirements for the compliance, traceability and safety of excipients have become increasingly stringent[2]. As a high-performance pharmaceutical excipient additive, ART101S Recombinant Human Albumin adheres to international pharmaceutical standards, integrates safety, compliance and versatility, and becomes a reliable partner for pharmaceutical enterprises in optimizing formulations, ensuring drug quality and meeting regulatory requirements.
Compliant and Traceable, Meeting Strict Regulatory Requirements. ART101S is specially developed for pharmaceutical excipient applications, strictly complying with Tonghua Artet's enterprise standard Q/ART 002-2024, as well as the Chinese Pharmacopoeia 2020 Edition and USP-NF 2023 Edition international standards, fully in line with the requirements of NMPA's "Good Manufacturing Practice for Pharmaceutical Excipients"[2]. Each batch of products undergoes rigorous quality inspection and provides a complete Certificate of Analysis (COA) report, which can trace the entire production process from raw material source to finished product delivery, effectively meeting the supplier audit and quality traceability needs of pharmaceutical enterprises, and reducing regulatory risks in drug registration and commercial production[2]. It is an ideal excipient additive for injectable drugs, biological products and other high-demand pharmaceutical formulations.
Safe and Pure, Eliminating Potential Contamination Risks. As a core pharmaceutical excipient, safety is the top priority. 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 as excipients[1][5]. It is a chemically defined, animal-origin-free and blood-free excipient, avoiding the risks of heterologous immunogenicity and exogenous contamination, and is especially suitable for the production of high-safety drugs such as vaccines, gene therapy products, cell therapy products and injectable biologics[1][5]. 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 drug formulation, laying a solid foundation for drug safety.
Multi-Functional Adaptation, Optimizing Pharmaceutical Formulations. ART101S has multiple functions to meet the diverse needs of pharmaceutical excipient applications, playing an important role in drug formulation optimization[1][5]: As a viral protectant, it can inhibit viral aggregation, stabilize protein conformation, resist thermal denaturation, and enhance the stability of viral vectors in vaccines and gene therapy products[1]; As a cell protectant, it acts as a non-permeable protectant to stabilize cell membranes, protect cells from stress damage, and is suitable for cell therapy and in vitro fertilization (IVF) formulations[1]; As a drug carrier, it has excellent hydrophilicity, biocompatibility and stability, can combine with insoluble small molecules to form soluble complexes, improve drug solubility and bioavailability, and is widely used in peptide fusion drugs and paclitaxel-albumin fusion drugs[1]. It is compatible with various pharmaceutical components such as hormones, vitamins and active ingredients, and can be flexibly added to different formulations to improve the stability and efficacy of finished drugs.
Stable Supply and Professional Support, Ensuring Worry-Free Use. 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 R&D and production technology[5]. We strictly implement the quality management system in line with GMP requirements, ensuring excellent batch-to-batch consistency of products, which avoids formulation fluctuations caused by excipient differences[2][5]. 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 excipient during transportation and storage, reducing inventory loss[6]. We provide professional technical support for pharmaceutical enterprises, including formulation adaptation guidance, addition amount recommendation and compliance consulting, to help enterprises optimize drug formulations and improve production efficiency.
Choosing ART101S as your pharmaceutical excipient additive means choosing compliance, safety and reliability. In the context of increasingly strict pharmaceutical supervision, it can help your enterprise meet regulatory requirements, optimize drug quality, enhance product competitiveness, and realize high-quality development in pharmaceutical production. Whether you are engaged in the production of injectable drugs, vaccines, cell therapy products or other biological products, ART101S can perfectly match your needs for pharmaceutical excipient additives!
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.
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