Recombumin® Elite 1 L Bioprocess Bag

Recombumin^® Elite 10 % (w/v) is a high-quality human and animal origin free, recombinant human albumin. Recombumin^® Elite, with its two presentations (50 mL glass vial; 1 L bioprocess bag) offers a solution to developers across a range of applications. This albumin formulation is not formulated with fatty acids and therefore may be more adaptable, with fatty acid modification, for developers keen to optimise specific unit operations.

Manufactured in an ICH Q7 cGMP facility, Recombumin^® Elite offers your process batch-to-batch consistency and predictable performance. Utilized in FDA, EMEA and MHRA approved products, early and late-stage clinical biopharmaceutical candidates, and as a coating for marketed high-class medical devices, Recombumin^® Elite has excellent market exposure. With an extensive regulatory package and drug master files registered in key markets, Recombumin^® Elite is a solution for those developing high-quality products, that demand quality and consistent raw materials.

Owing to the variability of performance that can be experienced when using different albumin sources and formulations, Sartorius also offers Recombumin^® Elite a 10 % (w/v) salt-based recombinant human albumin formulation. When requesting a sample get in touch with our experts to discuss what the best formulation for your process would be.

Our Recombumin^® portfolio results from four decades of research and development focused on recombinant human albumin enabled solutions. The formulation of your albumin really matters, as the manufacturing process and the ligands associated with albumin drive differential performance. Use the experience and know-how of our Sartorius team to help make your project a success!

Quick facts about Recombumin^® Elite

• - Recombumin^® Elite is used both up and downstream in several advanced therapies currently in development.

• - Recombumin^® Elite has an extensive DMF registered in key markets

Recombumin^® Elite can be utilized as an excipient, ancillary or raw material across several application areas including:

• Vaccine Manufacturing

• Biopharmaceutical Manufacturing

• Advanced Therapy Manufacturing

• Medical Device Coating

• Reagent manufacturer and formulation

*Excluding Russia*