PT  - JOURNAL ARTICLE
AU  - Michael Ronk
AU  - Yasser Nashed-Samuel
AU  - Jian Liu
AU  - Alejandra Gallegos
AU  - Yanxin Luo
AU  - Kiyoshi Fujimori
AU  - Kim Li
AU  - Hans Lee
TI  - Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
AID  - 10.5731/pdajpst.2019.011379
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.011379
4099  - http://journal.pda.org/content/early/2020/07/16/pdajpst.2019.011379.short
4100  - http://journal.pda.org/content/early/2020/07/16/pdajpst.2019.011379.full
AB  - Glass prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and patient safety from PFS requires implementation of an extractable and leachable program based on understanding of materials, risk assessment, review of existing literature and testing based on a sound scientific foundation. Extractables and leachables data generated as part of thorough and holistic program are presented for 5 PFS systems, including glass and plastic syringes, and 12 biologic drug products encompassing the implementation of traditional and single-use biotechnology manufacturing processes. The comprehensive extractables and leachables data presented demonstrate and substantiate a holistic extractable and leachable program designed to ensure product quality and patient safety.