Recombinant Albumin Facilitates Formulation Design of Stable Drug Products - Recombinant albumin can stabilize a drug product and assist in the administration and release of the active component. - Bi

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Recombinant Albumin Facilitates Formulation Design of Stable Drug Products
Recombinant albumin can stabilize a drug product and assist in the administration and release of the active component.


BioPharm International
Volume 25, Issue 3, pp. 40-44

A MULTIFUNCTIONAL EXCIPIENT

Successful formulation of therapeutic proteins and peptides that ensures adequate stability, manufacturability, and usability is essential for the biopharmaceutical manufacturer. Excipients are commonly used within the industry to reduce protein degradation, which can occur through physical or chemical pathways.

In this study, a recombinant albumin was seen to function as an effective multifunctional excipient to protect proteins against aggregation, especially amyloid-like fibril products, act as an antioxidant in preventing protein oxidation, and as a blocking agent to prevent nonspecific adsorption to surfaces. rAlbumin has the potential to reduce the total number of excipients required, especially for difficult to formulate molecules, simplifying the formulation strategy and accelerating development time in achieving the desired properties for the finished drug product.

Mark Perkins is a customer solution specialist, Novozymes Biopharma,
.

REFERENCES

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3. S.S. Bharate, S.B. Bharate, and A.N. Bajaj, J. Excipients and Food Chemicals, 1 (3), 3–26 (2010).

4. ICH, Q1A(R2) Stability Testing of New Drug Substances and Products (2003).

5. J.R. Fransson, J. Pharm. Sci. 86 (9), 1046–1050 (1997).

6. M.E. Cromwell, M. E. Hilario, and F. Jacobson, The AAPS Journal 8 (3), 572–579 (2006).

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