Virus Yield Improvement for Downstream Processing: Exbumin®, Excipient Recombinant Albumin

Published on 27 March 2023

Exbumin® provides significant regulatory and quality benefits over other excipients, surfactants, and animal-derived reagents.

Introduction

Biological manufacturers face many challenges in downstream processing unit operations of viral based therapeutics that impact the integrity, stability, and potency of their final drug product. Human Serum Albumin (HSA) has been shown to improve yield during common downstream purification unit operations such as tangential flow filtration, depth filtration, chromatography, sterile filtration, and final formulation of viruses and viral vectors. However, the use of serum-derived proteins is discouraged due to supply chain and regulatory concerns as well as concern about potential to introduce adventitious agents.

Here we demonstrate that a recombinant excipient-grade albumin, known as Exbumin®, increases viral yields via virus stabilization during downstream purification unit operations as well as in final formulation while retaining consistency and safety of the final product. Taken together, incorporation of Exbumin® into downstream viral purification protocols can provide benefit for large scale cell/gene therapy and vaccine manufacturing.

Exbumin® Recombinant HSA (“rHSA”) has benefits, such as:

• Recombinant – improved performance over native blood-sourced HSA
• Sustainable – no animal origin components
• Scalable – metric ton capacity removes supply chain concerns

Conclusion

Downstream processing holds many challenges for manufacturers, some of which include: preparing stable viral vectors, preventing degradation during manufacturing, handling and storage, and maintaining their long-term stability and efficacy. Albumin, among its many benefits, has been shown to significantly reduce vector and virus loss during downstream process unit operations. Recombinant Albumin (rHSA) is shown to consistently perform comparably, if not better, than native derived HSA. Exbumin® provides significant regulatory and quality benefits over other excipients, surfactants, and animal-derived reagents.

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