The One-Stop Shop For Freeze/Thaw And Cold Chain Process Optimization And Development

By Brian Fidler, engineering technician, and Muhammad Siddiqui, life science application engineer, Entegris

The current market for freeze/thaw equipment is limited to a few core suppliers and solutions. As more biopharmaceutical companies begin identifying a need for these technologies for their biotherapeutics, many may choose to incorporate freeze/thaw equipment into their processes without assessing and optimizing the system solution through testing and validation with their product. This can lead to product mismatch, suboptimal performance, and increased risk.

There exists a wealth of considerations related to the selection of components for a freeze/thaw application. Choosing the right container, transitioning away from more traditional but less effectual stainless-steel tanks, bottles, and even multi-layer bags, or selecting a secondary container to facilitate shipping – the supply considerations alone necessitate a comprehensive validation approach.  Couple this with identifying the optimal freeze/thaw technique and technologies, and having access to testing facilities represents a distinct advantage for drug manufacturers.

In order to mitigate the potential issues that can arise from inadequate testing, Entegris, a leading supplier of technology solutions across the manufacturing sector, has established the Technology Center, a world-class laboratory dedicated to affording customers access to testing for the equipment and containers that will form the foundation of their freeze/thaw process. Located at Entegris Headquarters in Billerica, Massachusetts, the Technology Center is designed to deliver optimized solutions, address gaps in market access, and build on the success of its Aramus bag assemblies, convening equipment and expertise to help companies optimize processes and achieve speed-to-market.