The supply chain and logistics for cell and gene therapies are especially critical to ensure the right patient gets the right treatment at the right time. Collaboration is the key to solving challenges such as data management and process variability, as stakeholders work towards a common goal—getting these life-saving treatments to the people who need them.

The cell and gene therapy industry can move faster by shoring up its weakest links. Q&A with GE Healthcare’s Phil Vanek about how to do it.

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.

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.

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.

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.

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.

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. 

In the biopharmaceutical industry (biopharma), process data is used in many ways throughout process development (PD) and the different production phases. This article outlines how connectivity and a comprehensive automation solution can ease technology transfer and scaling from PD to final manufacturing scale.

Through an industry collaboration, Cobra and GE were able to combine their expertise and experience and create a solution to meet the rising demand for high quality plasmid DNA.