NIBRT Study Assessed Single-Use Bags
The National Institute for Bioprocessing Research and Training (NIBRT) assessed the extractables and leachables (E&L) in 34 single-use bags used for cell cultivation in biopharmaceutical manufacturing; the bags were from different manufacturers and represented eight different types of multilayer films (1). Bags were extracted according to the BioPhorum Operations Group guidelines (2), and the extracts were analyzed using high-resolution mass spectrometry (HRMS) methods. NIBRT researchers found that polymer type and manufacturing date were the largest contributors to the different E&L profiles found in the different bags. The researchers noted that the types of additives or manufacturing processes for the plastic bags could change, which could change the nature of E&L.
NIBRT researchers have also implemented a method based on accelerated solvent extraction (ASE) and HRMS for plastic raw material extractables characterization, which is a crucial first step in assessing suitability for an intended use (3). The use of ASE for material selection follows industry best practices for conducting controlled extraction studies.
1. N. Dorival-Garcia et al., Anal. Chem. 90, 9006−9015 (2018).
2. W. Ding et al., Pharm. Eng. 34 (6) 1-11 (2014).
3. N. Dorival-García et al., Talanta 219, 121198 (2020).