Suitability-for-Use Considerations for Prefilled Syringes - Pharmaceutical Technology

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Suitability-for-Use Considerations for Prefilled Syringes
The nature of their application and their mode of use mean that prefilled syringes meet the regulatory definitions of immediate packaging or container–closure systems.

Pharmaceutical Technology

13. A.S. Rosenberg and A.S. Worobec, "A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 2: Considering Host-Specific and Product-Specific Factors Impacting Immunogenicity," BioPharm Int. 17 (12), 34–40 (2004).

14. I. Markovic, "Challenges Associated with Extractable and/or Leachable Substances in Therapeutic Biologic Protein Products," Am. Pharm. Rev. 9 (6), 20–27 (2006).

15. Z.Q. Wen et al., "Investigation of Contaminants in Protein Pharmaceuticals in Prefilled Syringes by Multiple Microspectroscopies," Am. Pharm. Rev. 10 (5), 101–107 (2007).

16. B. Sharma, "Immunogenicity of Therapeutic Proteins Part 2. Impact of Container Closures." Biotech. Adv. 25 (3), 318–324 (2007).

17. L.S. Jones, A. Kaufmann, and C.R. Middaugh, "Silicone Oil Induced Aggregation of Proteins," J. Pharm. Sci. 94 (4), 918–927 (2004).

18. D.E. Overcashier, E.K. Chan, and C.C. Hua, "Technical Considerations in the Development of Prefilled Syringes for Protein Products," Am. Pharm. Rev. 9 (7), 77–83 (2006).

19. B. Sharma et al., "Technical Investigations into the Cause of the Increased Incidence of Antibody-Mediated Pure Red Cell Aplasia Associated with Eprex," Eur. J. Hosp. Pharm. 5, 86–91 (2004).

20. K. Boven et al., "Epoetin-Associated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease: Solving the Mystery," Nephr. Dialy. Trans. 20 (suppl. 3), ii30–ii40 (2005)

21. J. Pang et al., "Recognition and Identification of Leachables in EPREX Prefilled Syringes: An Unexpected Occurrence at a Formulation-Component Interface," PDA J. Pharm. Sci. Technol. 61 (6), 423–432 (2007).

For more on this topic, see "Big Shot: Developments in Prefilled Syringes" in the March 2007 issue of Pharmaceutical Technology.


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