Risk management strategies for safety qualification of extractable and leachable substances in therapeutic biologic protein products

American Pharmaceutical Review

Volumn 12, Issue 4, 2009, Pages

  Markovic, Ingrid ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM OXIDE; ALUMINUM PHOSPHATE; BROMINE; BUTYLCRESOL; DRUG VEHICLE; EDETIC ACID; HUMAN SERUM ALBUMIN; LATEX; METAL ION; METALLOPROTEINASE; METHIONINE; ORGANIC SOLVENT; PHOSPHATE; POLYSORBATE; PROTEIN; TUNGSTEN;

ARTICLE; CARDIOVASCULAR DISEASE; DRUG CARCINOGENICITY; DRUG CONTAMINATION; DRUG DEGRADATION; DRUG EFFICACY; DRUG FORMULATION; DRUG IMPURITY; DRUG ISOLATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; ENDOCRINE DISEASE; HUMAN; IMMUNOGENICITY; LD 50; LEACHING; NONHUMAN; PATIENT SAFETY; PROTEIN AGGREGATION; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; RISK MANAGEMENT; SHELF LIFE; SYRINGE;

EID: 67649945974     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. OSTENBERG RE: Potential toxicity of extractables and leachables in Drug Product. American Pharmaceutical Review (2005) 8:64-67 (Pubitemid 44490942)
2. CAFMEYER NR and WOLFSON BB: The possible leaching of diethyl phthalate into levothyroxine sodium tablets. American Journal of Hospital Pharmacy (1991) 48:735-739.
3. CDRH/FDA guidance: Safety assessment of di(2-ethylhexyl) phthalate (DEHP) released from PVC medical devices. Available at: http://www.fda.gov/cdrh/ost/ dehp-pvc.pdf.
4. GAYATHRI NS, DHANYA CR, INDU AR et al: Changes in some hormones by low doses of di(2-ethyl hexyl) phthalate (DEHP), a commonly used plasticizer in PVC blood storage bags and medical tubing. Indian Journal of Medical Research (2004) 119:139-144. (Pubitemid 38618698)
5. MARKOVIC, I. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: A risk-based perspective. Expert Opin Drug Saf. (2007) 6:487-491. (Pubitemid 351308208)
6. WANG, Q. Selection of analytical techniques for pharmaceutical leachables studies. Am. Pharm. Rev. (2005) 8:38-44.
7. Anon. U.S. Pharmacopeia, 28th ed. Rockville, MD: The U.S. Pharmacopeial Convention, Inc.; 2004. 〈381〉 Elastomeric Closures for Injections, Physicochemical Test Procedures.
8. Anon. U.S. Pharmacopeia, 28th ed. Rockville, MD: The U.S. Pharmacopeial Convention, Inc.; 2004. 〈87〉 Biological Reactivity Tests, In Vitro.
9. Anon. U.S. Pharmacopeia, 28th ed. Rockville, MD: The U.S. Pharmacopeial Convention, Inc.; 2004. 〈88〉 Biological Reactivity Tests, In Vivo.
10. ICH Q3C(R3). Impurities: Guideline for residual solvents. Available at http://www.ich.org/LOB/media/MEDIA423.pdf.
11. Product Quality Research Institute Leachables and Extractables Working Group, Safety thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, 2006.
12. MARKOVIC I: Challenges associated with extractable and/or leachable substances in herapeutic biologic protein products. American Pharmaceutical Review (2006) 9:20-27.
13. Boven K, Stryker S, Knight J, Thomas A, van Regenmortel M, Kemeny DM, Power D, Rossert J, Casadevall N. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int. 2005, 67:2346-2353. (Pubitemid 41623396)