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, mrpk@novozymes.com
.
REFERENCES
1. Crowley, P.J. and L.G. Martini, Chemistry Today
28 (5), 7–13 (2010).
2. F.G. Vogt and A.S. Kord, J. Pharm. Sci.
100 (3). 797–892 (2011).
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).
7. W. Wang et al., J. Pharm. Sci.
96 (1), 1–6 (2007).
8. L.A. Kueltzo et al., J. Pharm. Sci.
97 (5), 1801–1812 (2008).
9. L. Perrone et al., ChemBioChem
11 (1), 110–118 (2010).
10. Y. Jeyachandran et al., Langmuir
25 (19), 11614–11620 (2009).
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