Extractables analysis of single-use flexible plastic biocontainers

Area of Science:

• Biopharmaceutical Manufacturing
• Analytical Chemistry
• Materials Science

Background:

• Single-use bioprocess equipment offers advantages over stainless steel but poses risks of compound leaching.
• Extractable profiling is essential for qualifying single-use systems in drug manufacturing.
• Understanding leachables ensures process performance, drug quality, and patient safety.

Purpose of the Study:

• To develop and evaluate an effective extraction solvent system for single-use bioprocess equipment.
• To identify organic extractable compounds from commercially available single-use bags.
• To assess the potential impact of extractables on biopharmaceutical manufacturing processes.

Main Methods:

• Developed a novel extraction solvent system for aggressive conditions simulating aqueous-based biopharmaceutical manufacturing.
• Employed a non-targeted analytical strategy to identify a broad range of extractable compounds.
• Analyzed four types of commercially available single-use bags.

Main Results:

• Identified a total of 53 organic compounds from the single-use bags.
• The majority of identified compounds were degradation products of polymer additives.
• Successfully extracted and identified a compound detrimental to mammalian cell growth.

Conclusions:

• The developed extraction solvent system is effective for evaluating organic extractables in single-use bioprocess equipment.
• Polymer additive degradation products are significant extractables in single-use systems.
• Identifying harmful extractables is critical for ensuring the safety and efficacy of biopharmaceutical manufacturing.