What are the benefits of adopting SUTs?Single-use technologies for biopharmaceuticals are defined as disposable products, which are intended for one-time use, made of various types of gamma-sterilized plastics like polyethylene. They have several advantages over reusable systems because they allow more production flexibility, improve sterility assurance, are more cost-effective, and decrease time-to-market.
- Cost – Reduced manufacturing costs by elimination of cleaning and sterilization steps
- Speed – Time and labor savings during set-up and between operational cycles
- Sterility – Disposable components reduce cross-contamination risks between batches
What factors should I focus on when selecting SUTs for CGT manufacturing?There are many SUTs available for biopharmaceuticals but the majority of SUTs on the market were originally designed for other purposes and have been adapted for CGT processes, thus careful attention and research must be done to qualify their suitability for their intended use prior to selection. Key factors to consider include:
- Sterility – Sterility assurance level (SAL) of 10-6 in order to meet regulatory mandated sterile processing requirements for CGT use
- Low extractable and leachable (E&L) profiles – Cell types used in CGT are highly sensitive to substances that enter the product stream from SUT components; therefore, keeping these levels low can mitigate the impact on product quality and safety