Application Notes & Case Studies

1. 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.

2. The Effect Of Rocking Rate And Angle On T Cell Cultures Grown In Expansion Systems 2/23/2020

   Ensuring optimal and maximal T cell production is critical for adoptive immunotherapy and its continued success. The Xuri Cell Expansion System is an important component of the clinical manufacturing process so we sought to investigate the effect of the rocking rate and angle on the expansion of T cells.

3. Scale-Up Of CHO Cell Fed-Batch Cultures In HyClone™ ActiPro™ Medium Supplemented With Cell Boost™ 7a And 7b 2/21/2020

   The most widely used cell lines for biopharmaceutical production of therapeutic proteins originate from CHO cells. These cells are robust in culture and are able to produce a variety of recombinant glycoproteins at high levels in large scales. This application note compares cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

4. Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures Using HyClone™ ActiPro™ Medium And Cell Boost™ 7a And 7b Supplements 2/21/2020

   ActiPro cell culture production medium is intended to be used in combination with Cell Boost 7a and 7b supplements to enhance recombinant protein production in fed-batch or perfusion processes. This work demonstrates the development of a fed-batch process for a CHO cell line producing a monoclonal antibody (mAb). The results emphasize the importance of an appropriate feeding strategy to achieve optimal cell growth and productivity.

5. Cell Culture Titer & Protein Quality 2/21/2020

   When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a Design of Experiment (DoE) and empirical approach. Here is an example of how to do it.

6. Evaluating The Economics Of Today’s Biomanufacturing Strategies: Can You Afford The Cost Of Failure? 2/21/2020

   Prior to making critical decisions about its strategy, a small biotech company completed an economic evaluation of different manufacturing options to ensure it was selecting the one that best fit its drug development needs. 

7. E-Book - Package Inspection Considerations For Class III Medical Devices 2/20/2020

   Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection method. This e-book covers a variety of inspection methods and benefits and downfalls for each one.

8. ‘Smart Devices’ vs. ‘Smart Design’: Demonstrating The Value Of Polymeric PDC Technology Upon User-Centric Autoinjector Design 2/18/2020

   Oval Medical has developed a novel Prefilled Primary Drug Container (PDC) that resolves many known drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies. This article discusses the benefits of using these technologies in user-centric autoinjector designs.

9. Improved Autoinjector Design: Demonstrating Highly Consistent Performance Achieved Through The Integration Of A Cyclic Olefin Syringe 2/18/2020

   Oval Medical has developed a novel Prefilled Primary Drug Container (PDC) that resolves many known drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies. This article presents performance data for the Sumalen Ovali 0.5ml / 0.6mg Sumatriptan autoinjector manufactured using a commercially representative process.

10. Pharmacuetical Manafacturer Improves Chromatography And Batch Comparisons Using Data And Analytics 2/10/2020

    For clinical or commercial scale manufacturing in the pharmaceutical and biotech industries, just finding the right data to analyze can consume significantly more time than it does to perform the analysis. Having the right applications to store and contextualize the data is imperative, but being able to obtain business value by accessing and interpreting it quickly and effectively can have a huge impact on decision-making and, ultimately, the business’s bottom line.