From Smart Tags to Brilliant Tags: Advances in Drug Stability Monitoring

Nov 01, 2005
Volume 18, Issue 11

Therapeutic proteins, in particular recombinant analogs of naturally occurring hormones and other body proteins, are another area where improved stability monitoring could prove useful. Degraded proteins tend to aggregate and also can assume other unnatural chemical states. These unnatural states tend to activate the body's immune system, potentially creating an immune response against the therapeutic protein. Such antibodies can act to neutralize the effect of the therapeutic protein, or worse, act to neutralize the effect of the body's own naturally occurring hormones. In these cases the degraded form of the drug can prove to be potentially harmful.8 Fortunately such recombinant protein therapeutics tend to be high-value drugs and can easily support the relatively minor additional costs of brilliant-tag packaging.

Brilliant tag technology can help insure availability of safe drugs in emergency situations, help promote ambulatory infusion, and potentially help minimize adverse drug reactions to certain classes of therapeutic proteins.

CONCLUSION

Due to advances in modern electronics, inadvertent use of temperature-deteriorated drugs is now a preventable problem. Brilliant tags are now available for pilot evaluation studies. These tags can be rapidly programmed to simulate the temperature stability of almost any drug. As this type of brilliant tag becomes more widely used, volume manufacturing should drive the cost-per-tag down to where they may become a viable option for nearly all temperature-sensitive drugs and vaccines.

Stephen E. Zweig, Ph.D., CEO, CliniSense Corporation, 15466 Los Gatos Blvd., 109-355, Los Gatos, CA 95032, 408.348.1495,

REFERENCES

1. Galazka A, Milstien J, Zaffran M. Thermostability of vaccines. World Health Organization Global Program for Vaccines and Immunization WHO/GPV/98.07 (1998).

2. Heatmarker, TempTime Corporation, Morris Plains, New Jersey http:// http://www.lifelinestechnology.com/health.html.

3. World Health Organization. Technical review of vaccine vial monitor implementation. http:// http://www.who.int/vaccines-access/vacman/vvm/vvmforall.htm, 2002.

4. Bell, et. al. Risk Factors for Improper Vaccine Storage and Handling in Private Provider Offices. Pediatrics 2001; 107(6); E100.

5 Zweig SE. Technologies for monitoring IVD stability. IVD Technology 10(5) 59-63, June 2004.

6. Food and Drug Administration Combating counterfeit drugs: A report of the Food and Drug Administration. 2004. http:// http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html.

7. Texas Instruments, MSP430 microprocessor, http:// http://www.msp430.com/.

8. Rosenberg A, Worobec A. A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 2: Considering Host-Specific and Product-Specific Factors Impacting Immunogenicity. Biopharm International, December 1, 2004.


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