BTXPure™

Botulinum toxin is a potent neurotoxin produced by the bacterium Clostridium botulinum and is manufactured for therapeutic and cosmetic applications.

Purifying botulinum toxin can be significantly challenging for the industry due to its potent toxicity, complex molecular structure, and the need for high purity for safe application. The toxin production process often results in low yields that require costly and time-consuming purification steps. BTXPure™ can significantly improve both yield and purity, enabling a cost-effective, streamlined approach to meet the high standards required for safe and effective commercial use.

BTXPure™ is a botulinum toxin binding adsorbent which was designed and developed by Astrea Bioseparations Ltd and leaders in the botulinum toxin industry for the capture and purification of botulinum toxin. BTXPure™ is a mixed-mode resin that shows preferential binding towards a range of botulinum toxins forms (wild-type botulinum toxin and a range of botulinum toxin serotypes, as well as recombinant botulinum toxin) which, with optimization, can be selectively eluted. It features a unique mixed-mode synthetic ligand bound to PuraBead^® 6HF, a robust 6% highly cross-linked, near-monodisperse agarose bead matrix. This advanced design ensures excellent flow properties and strong chemical stability, making BTXPure™ ideal for high-demand purification processes.

Available as bulk resin or in pre-packed columns, offering a streamlined, ready-to-use solution for process development and manufacturing.

BTXPure™ is produced under an ISO 9001 quality system, and bulk resin formats are available to support cGMP development and manufacturing-scale processes.

BTXPure™ is fully alkali-stable and supports cleaning and sanitization with up to 1 M NaOH, ensuring robust performance across multiple purification cycles.

The resin supports operational flow rates of up to 600 cm/h, offering excellent throughput and scalability for demanding bioprocessing environments.

Yes, BTXPure™ is available in pre-packed Evolve^®R columns (5 mL and 50 mL) for screening and development, bulk slurry formats, and larger-scale single-use Evolve^®D columns for pilot or commercial use, providing flexibility from early development through to full-scale production. 

BTXPure™ effectively binds recombinant botulinum toxin and allows for optimized elution, offering a versatile platform for both native and engineered toxin forms. 

Yes, Astrea Bioseparations provides comprehensive regulatory support files for BTXPure™ to assist customers with their regulatory filings and compliance needs.