White Paper

Filling Industry Gaps With Dedicated Cell & Gene Therapy Fluid Transfer Sets

Regenerative medicine and therapeutic stem cell therapy GettyImages-1334489810

 While a wide variety of ancillary products, including single-use disposables, exist to support the cell therapy industry. Many have been designed for other industries and purposes resulting in cell therapy manufacturers having to adapt to pre- existing processes. Given the critical limitations that come with many autologous cell-based therapies, it is important to provide and implement products that will help to enhance quality, safety, and commercial viability.

A wide number of ancillary tools specifically developed to support the blood transfusion industry have been adopted into CGTs manufacturing protocols. Transfer sets, often referred to as accessory tubing sets, are used regularly within this field and have the potential to be used in nearly every step of the manufacturing process.

These ancillary components are mainly used to transfer fluids or reagents from container to container, and are an especially critical component enabling CGT production. Given the usage frequency and the consideration that autologous CGT products are often limited to a single product per intended patient, transfer sets should be selected that provide the right components, performance and quality assurance. The current range of commercially available transfer sets or accessory sets were not designed for CGT manufacturing and therefore lack key industry requirements. Incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.

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