TY - JOUR T1 - Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 627 LP - 643 DO - 10.5731/pdajpst.2019.011379 VL - 74 IS - 6 AU - Michael Ronk AU - Jian Liu AU - Alejandra Gallegos AU - Yanxin Luo AU - Kiyoshi Fujimori AU - Kim Li AU - Hans Lee AU - Yasser Nashed-Samuel Y1 - 2020/11/01 UR - http://journal.pda.org/content/74/6/627.abstract N2 - 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 supported by a sound scientific foundation. Extractables and leachables data generated as part of a thorough and holistic program are presented for five PFS systems, including glass and plastic syringes filled with 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. ER -