Application Notes & Case Studies

1. End-User Evaluation Of 30 L And 300 L HyPerforma Single-Use Fermentors And Scale-Down Model 3/27/2020

   In moving processes from bench to pilot and ultimately production fermentors, it is critical to have a reliable scaledown model. Scale-down models can vary depending on the media, strain, and process conditions. In this case, a customer wanted a scale-down model of the Thermo Scientific™ HyPerforma™ Single-Use Fermentor (S.U.F.) in order to establish what fermentation processes could be scaled into the S.U.F., in particular for the production of plasmid DNA.

2. Use Of Nunc Cell Factory Equipment To Accelerate Workflows And Increase Product Consistency 3/27/2020

   Scaling up adherent cell culture can be a difficult process for many vaccine, cell therapy, gene therapy, and viral vector manufacturers. Some cells can alter their properties if they are not cultured in specific conditions. The simplest way to mitigate all these risks is by using a multi-layered vessel, such as the Thermo Scientific™ Nunc™ Cell Factory™ system, in a closed system with automation equipment.

3. CCI Test Method Validation For Pre-Filled Syringes 3/18/2020

   Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. Read how method validation is used to demonstrate sufficient accuracy and reproducibility of a method, in this case to detect CCI defects at the plunger seal of a pre-filled syringe.

4. Scale-Up Of Fed-Batch Process Utilizing Dynamis Medium And EfficientFeed C+ Supplement In HyPerforma S.U.B.s 3/16/2020

   One key factor for ensuring comparable growth and productivity during cell culture scale-up is pH control. pH impacts many factors in this process, including specific productivity, cell growth, and cell metabolism. Here we demonstrate the scalability of a fedbatch process of CHO cells in Gibco™ Dynamis™ Medium with Gibco™ EfficientFeed™ C+ Supplement, utilizing a pH shift strategy.

5. TPE Tubing Weld Testing 3/3/2020

   This tech bulletin demonstrates the aseptic weldability and sealability of thermoplastic elastomer (TPE) tubing for use in numerous applications requiring aseptic liquid transfer. 

6. Recirculation Flow Testing A Biocontainer 3/3/2020

   A common challenge of using rocker bioreactors in perfusion mode is the transfer of air into the recirculation pathway. Here, a new anchored dip tube designed to prevent the problem is evaluated.

7. Conductivity Testing Of Mixing Systems 3/3/2020

   This technical bulletin highlights the results of conductivity testing to characterize recirculation mixing performance of single-use systems deployed in Meissner’s QuaDrum rigid outer containers (ROCs).

8. Pump Life Testing Of TPE Tubing 3/3/2020

   The ability to operate biopharmaceutical tubing in a peristaltic pump can be a critical performance attribute in liquid management applications and unit processing operations. It is often the case that tubing, which has been qualified for use in welding operations, is incompatible with peristaltic pump use, and vice versa. In this technical bulletin both non-sterile and gamma irradiated BioFlex® TPE tubing and C-Flex® 374 tubing were tested for pump life performance by subjecting samples to continuous pumping until failure was observed.

9. Comparative TOC Rinse-Up Study Of Pharmaceutical Tubing 3/3/2020

   Total organic carbon (TOC) content provides a measure of the cleanliness of single-use materials and components considered for use in pharmaceutical manufacturing processes. In this technical bulletin, the results of a rinse up study to measure the TOC from four different tubing types is presented. The silicone tubing were each rinsed with deionized (DI) water, which was then sampled and analyzed off-line to determine the TOC content from each.

10. Controlled Endpoint In Cryopreservation 2/24/2020

    Successful cryopreservation of cells requires a controlled cooling rate. Cooling too rapidly or too slowly could lead to a poorer outcome. This application note demonstrates how controlled-rate cooling is achieved using equipment such as VIA Freeze controlled-rate freezers.