During scale-up of cell culture in the manufacturing of biotherapeutics, specialized approaches are employed to address the unique characteristics of these bioproduction processes. Cell culture conditions and consistent growth are critical to the biochemistry of the active components during expression, recovery, and purification.
The Thermo Scientific™ single-use technologies addresses these specialized needs of biotherapeutic development and manufacturing. Single-use products have revolutionized the field of biomanufacturing: with single-use technologies, it’s now possible to make small amounts of drug product that might be suitable for preclinical and clinical testing. Prior to the availability of these single-use systems, this would have required substantial facilities to produce the material needed.
Single-use technologies are used throughout the bioproduction workflow, from buffer and media preparation to bioreactor cultures for vaccines to the storage and shipping of intermediates and bulk biologics.
We offer a comprehensive suite of single-use technology products to support all your bioproduction needs, including bioprocess containers (BPCs), manifold assemblies, outer support containers, single-use fermentors, single-use bioreactors, and single-use mixers. Our single-use technologies are also designed to integrate perfectly with our portfolio of cell culture serum, media, supplements, buffers, and other process liquids.
Featured single-use technology products
Single-use mixing products for liquid–liquid and powder–liquid mixing of media, buffers, intermediates and final products.
Standard and custom BPCs, tubing sets, and manifolds, covering a range of applications, sizes, and connection systems.
Our systems are designed to meet the high demands of industrial microbiology with efficient mass transfer, mixing, and temperature control.
The Thermo Scientific™ inSITE™ Integrity Testing system is a post-installation, pre-use integrity testing system designed to detect flaws at the most critical stage
Video: CMC Biologics discusses single-use technology
Three CMC Biologics executives share their perspective of single-use technology and the significance of working with a reliable partner such as Thermo Fisher Scientific, which include:
- Redundancy of supply
- Reliability with regards to timing and quality
- Collaborative approach to meeting customer needs
Advantages of single-use technologies:
- Reduced contamination risks
- Lower initial investment costs
- Lower facility and operating costs
- Speed, efficiency, and flexibility
- Single-use fermentors—These systems are engineered for optimal oxygen mass transfer, mixing, and temperature control and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work are streamlined—offering you cost savings and efficiency.
- Single-use bioreactors—These bioreactors are designed as stirred-tank reactors for animal cell culture, using traditional stainless steel bioreactor principles to help ensure optimal cell culture performance. They also have the unique advantage of utilizing completely single-use product contact surfaces to reduce contamination and minimize cleanup.
- Single-use mixers—Our mixers address the needs of proper preparation and mixing of component molecules found in cell culture media, buffers, and other process liquids. These are designed for the liquid–liquid and powder–liquid mixing of media, buffers, intermediates, final products, process liquids, and suspensions—with all the benefits of single-use technology.
- Single-use bioprocessing container systems—Our BPCs and tubing assemblies are disposable, single-use flexible container systems. They’re commonly used for critical liquid handling applications throughout bioprocessing operations. BPC systems are cost-effective alternatives to conventional stainless steel systems, and are scalable from benchtop to production.
- Outer support containers—Our outer support containers are designed to hold BPC and tank liners for in-process and transportation needs. Support containers are reusable and matched to the chamber dimensions, the weight of the contents, and the functionality required.
- Integrity Testing—Our integrity testing system is a true point-of-use system that allows users in the biophramaceutical manufacturing environment to confirm the integrity of a single-use bioprocess container inside the tank that is about to be filled.
- Heat Transfer—Our modular heat exchanger is an innovative modular system that uses single-use BPCs as the sterile fluid path. The BPCs fit tightly between five stainless steel plates, efficiently transferring heat in a counter-current flow path.
Integrated bioprocessing solutions
Have a question about single-use technologies, Gibco™ media, Applied Biosystems™ POROS™ chromatography resins, Applied Biosystems™ SEQ rapid contaminant tests, or our Gibco™ Cell Therapy Systems™ products? Click below to access product brochures, training videos, mobile apps and more.