Protein Sensitivity to Tungsten - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Protein Sensitivity to Tungsten
The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography.


Pharmaceutical Technology
pp. s28-s32

Conclusion

Assays based on turbidity and SEC can be used to evaluate protein sensitivity to tungsten in order to optimize formulations for the packaging of biologics in glass prefilled syringes. Ionic strength and pH are important elements in the aggregation of proteins by tungstate polyoxyanions. An acidic pH is necessary for the generation of tungstate polyoxyanions and aggregation may be blocked by increasing the ionic strength of the formulation. This suggests that the interaction of polyoxometalates with proteins is primarily electrostatic. Some proteins precipitate with tungstate more readily than others, but a net positive charge is essential. Although protein size does not appear to be important, other factors related to a protein's structure may play a role in determining binding and aggregation by tungstate polyoxyanions. Syringes made of plastic, which are free of both silicone oil and tungsten, should be considered for use with sensitive biomolecules.

Vinod Vilivalam*, PhD, is director of strategic market and technical development, Lloyd Waxman is a principal scientist, West Analytical Labs, Tadd Steeley is a senior chemist, all at West Pharmaceutical Services, 101 Gordon Drive, Lionville, PA 1934, tel: 610.594.3147,
.

*To whom all correspondence should be addressed.

References

1. L.S. Jones, A. Kaufmann, and C.R. Middaugh, J. Pharm. Sci. 94 (4), 918–927 (2005).

2. A.S. Rosenberg, AAPS Journal 8 E501–E507 (2006).

3. W. Liu et al., PDA J. Pharm. Sci. Tech. 64 (1), 11–19 (2010).

4. Y. Jiang et al., J. Pharm. Sci. 98 (12), 4695–4710 (2009).

5. J.S. Bee et al., J. Pharm. Sci. 98 (9), 3290–3301 (2009).

6. M.T. Pope, Heteropoly and Isopoly Oxometalates (Springer-Verlag, New York, 1st ed., 1983).

7. L.S. Jones, A. Kaufmann, and C.R. Middaugh, J. Pharm. Sci. 94 (4), 918–927 (2005).

8. I. Markovic, American Pharmaceutical Review 9 (6), 20–27 (2006).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
10%
Regulatory compliance
33%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here