RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 627
OP 643
DO 10.5731/pdajpst.2019.011379
VO 74
IS 6
A1 Michael Ronk
A1 Jian Liu
A1 Alejandra Gallegos
A1 Yanxin Luo
A1 Kiyoshi Fujimori
A1 Kim Li
A1 Hans Lee
A1 Yasser Nashed-Samuel
YR 2020
UL http://journal.pda.org/content/74/6/627.abstract
AB 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.