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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here