Botulinum toxin (commonly referred to as "botox") is a potent neurotoxin produced by Clostridium botulinum. It is widely used in aesthetic medicine for wrinkle reduction and body contouring, as well as in clinical treatment fields such as neurology, rehabilitation, and urology. Moreover, its indications are continuously being explored and expanded. Currently, most commercially available botulinum toxin products worldwide are natural type A botulinum toxin, and the market is mainly dominated by major products such as BOTOX®, Dysport®, XEOMIN®, Letybo®, NABOTA®, and Hengli®. With the development of recombinant protein technology, after years of research by scientists and R&D experts in the botulinum toxin field, recombinant type A botulinum toxin is expected to lead the botulinum toxin industry into a new era, thanks to its advantages of high purity, low biological risk, low immunological risk, high production efficiency, and low cost.

Due to botulinum toxin’s high toxicity, complex molecular structure, and the high purity required for its safe application, its purification process still poses significant challenges in large-scale production. In particular, the yield of natural botulinum toxin is generally low, and its purification usually consumes a great deal of time and cost. BTXPure? can significantly improve the yield and purity of botulinum toxin, thereby enabling an economical, efficient, and streamlined approach that is safe and effective, meeting the high standards required for commercial production.

BTXPure? is a multimodal chromatography resin designed and developed by Astrea Bioseparations, specifically for the capture and purification of botulinum toxin. It exhibits excellent binding performance for various types of botulinum toxin, including natural type A, B, and E botulinum toxins, as well as recombinant botulinum toxin. The matrix of BTXPure? is high-cross-linked agarose with uniform particle size (PuraBead®6HF), modified with unique multimodal ligands, and it can operate at a flow rate of up to 600 cm/h. BTXPure? resin has strong alkali resistance, remaining stable in sodium hydroxide solutions up to 1.0 M, making it suitable for strict cleaning and disinfection procedures.

The production of BTXPure? multimodal chromatography resin adheres to the ISO 9001 quality management system and can meet the needs of large-scale production processes. Astrea Bioseparations also offers a series of ready-to-use, pre-packed Evolve®D columns, providing optimized solutions for rapid launch into production. In addition, BTXPure? multimodal chromatography resin is available in a variety of large packaging sizes and pre-packed columns to meet the requirements of cGMP production processes. Astrea Bioseparations can provide customers with complete regulatory documentation for BTXPure? resin and offer support and assistance for the filing of customers’ process workflows.

Key Advantages of BTXPure?

· Suitable for the purification of various types of botulinum toxin, including natural type A, B, E, and recombinant botulinum toxin;

· Economical and efficient, simplifying downstream purification processes;

· Improves the recovery rate and purity of botulinum toxin;

· Strong alkali resistance, suitable for strict cleaning and disinfection procedures, and can be reused multiple times;

· Multiple options of pre-packed columns and bulk resin;

· Comprehensive regulatory documentation support, meeting cGMP production requirements.

BTXPure? Ordering Information

Bulk Resin

Pre-packed Column

Astrea Bioseparations Incorporated in 1987 as a spin-off from the University of Cambridge, Astrea Bioseparations has over 30 years of experience in the R&D and manufacturing of chromatography media, and stands as a world-class supplier of chromatography media products and services. To date, more than 21 manufacturing processes using Astrea’s products have obtained approvals from the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).

Astrea Bioseparations operates 3 R&D and manufacturing facilities worldwide, focusing on providing industry-leading chromatography media and technical services for the biopharmaceutical (large molecule) and Cell & Gene Therapy (CGT) sectors. The novel nanofiber-based chromatography technology launched by Astrea Bioseparations addresses the issues of low capacity and time-consuming processes associated with traditional bioseparation tools. It enables faster, more environmentally friendly, and more cost-effective purification processes, fully aligning with the needs of today’s biotherapeutic innovation.

XMJ is the China distributor of Astrea Bioseparations, providing users with comprehensive technical support and after-sales service. Please feel free to call XMJ's customer service hotline at 400-050-4006 or visit the website www.gp82.cn for more information.