Challenges associated with extractable and/or leachable substances in therapeutic biologic protein products

American Pharmaceutical Review

Volumn 9, Issue 5, 2006, Pages

  Markovic, Ingrid ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

DRUG PACKAGING; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; LEACHING; PATIENT SAFETY; PHYSICAL CHEMISTRY; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; ULTRAFILTRATION;

EID: 39749147173     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. Container Closure Systems for Packaging Human Drugs and Biologics, Chemistry Manufacturing and Controls Documentation, CDER/CBER/FDA Guidance for Industry, 1999.
2. Anon. U.S. Pharmacopeia, 28th ed. Rockville, MD: The U.S. Pharmacopeial Convention, Inc.; 2004. 〈87〉 Biological Reactivity Tests, In Vitro.
3. Anon. U.S. Pharmacopeia, 28th ed. Rockville, MD: The U.S. Pharmacopeial Convention, Inc.; Please circle #20 Markovic_ads 10/2/06 1:04 PM Page 7 EXTRACTABLES/LEACHABLES 27 American Pharmaceutical Review 2004. 〈88〉 Biological Reactivity Tests, In Vivo.
4. Northup, SJ. Assessing the biological safety of extractable and leachable chemicals in pharmaceutical and medical products. Am. Pharm. Rev. 2005, 8 (4), 38-43.
5. 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 (6), 2346-53.
6. Wang, Q. Selection of analytical techniques for pharmaceutical leachables studies. Am. Pharm. Rev. 2005, 8 (6), 38-44.
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8. Kauffman JS. Trends in Impurity Analysis: Determination of extractables, leachables, residual solvents and unknowns by Mass Spectrometry. Pharm. Tech. 2003, www.pharmtech.com.
9. Jenke D. Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. J. Pharm. Sci. Technol. 2002, 56 (6), 332-71.
10. Anon. U.S. Pharmacopeia, 28th ed. Rockville, MD: The U.S. Pharmacopeial Convention, Inc.; 2004. 〈381〉 Elastomeric Closures for Injections, Physicochemical Test Procedures.
11. Schellekens H and Jiskoot W. Eprex-associated pure red cell aplasia and leachates. Nature Biotechnology 2006, 24(6), 613-614.
12. Jones LS, Kaufmann A and Middaugh RC. Silicone oil induced aggregation of proteins. J. Pharm. Sciences 2005, 94(4), 918-927.