Temperature control during sourcing, manufacturing, and delivery of cell therapies is crucial, as fluctuations can affect viability and function of the cells, and potentially, the overall efficacy and safety of the therapeutic product. In many cell therapy workflows, source cells arrive cryopreserved at LN2 temperatures (-150 to -196 °C) and post-manufacturing, cells are again cryopreserved and stored in vapor- or liquid phase LN2 prior to their use in the clinic. In either case, containers filled with dry ice (-50 to…

Traditional medium optimization strategies are labor intensive, costly, and time consuming. In this project, high-throughput screening technology was adopted along with statistical design to reduce costs and decrease time for optimizing culture conditions for maximized antibody production from a custom Chinese hamster ovary (CHO) cell clone. The presented work includes two phases: phase 1 for basal medium optimization and phase 2 for feed optimization. Phase 1 and phase 2 each have two rounds. A DoE screening methodology was used to…

Seed culture expansion is commonly performed in several consecutive batch cultures. Starting from a cryopreserved cell stock, the initial culture expansion is typically performed in shake flasks, while the final steps are performed, at greater scales, in bioreactor vessels. Such a procedure is time-consuming and labor intensive with multiple steps that introduce risk for mishandling and contamination. This work describes how the use of perfusion in the seed culture expansion process, in combination with the use of high-density cell banks,…

During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug dis-covery. High titers are often obtained from Human Embryonic Kidney (HEK) 293 derived cell types; however, the use of different host cells between early stage transient and later stable protein production is a concern and can lead to the advancement of false-positive candidates. Chinese hamster ovary (CHO) cells are a desirable target cell type due to growth characteristics and a history of regulatory approval;…

ASI-Life Sciences commissioned a CFD study of our imPULSE single-use mixing systems to predict and characterize the mixing performance of the systems across small, medium and large vessels and fluid viscosities. One characterization from the study as you will see in Figure 1 of the poster was the rate at which the momentum from the mixing disc transferred through the fluid. As you can see in the Figure within 5 seconds, fluid motion was achieved in the 250 L, 1,500…

The implementation of single-use technologies for pharmaceutical product development continues to gain momentum; this trend is due to the advantages of increased flexibility, speed of implementation and lower capital investment. In particular, they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact and level of leachables in the final drug substance. Typically this concern is addressed through a risk assessment utilizing extractable…

Frozen storage is commonly performed and enables manufacturing process flexibility, long-term product stability and minimizes logistics challenges.  While single-use containers are available for storage and transport of frozen products, some require a significant investment while others don’t offer the necessary support and protection. Using films and bags not designed for frozen storage applications can be detrimental.   Charter Medical recently developed a new family of single-use frozen storage and transport solutions. The Freeze-Pakâ„¢ STS (FP-STS) bio-containers and supporting secondary single-use…

Mammalian cells are a widely used expression platform for the production of recombinant therapeutic proteins or viral particle-based vaccines since they typically perform appropriate protein post-translational modifications and authentic viral particle assembly. Of the available mammalian cells, CHO and HEK 293 are some of the most industrially relevant cell lines because they are cGMP compliant and are able to grow in suspension in a variety of serum-free media. Of note, production of human therapeutics in mammalian cell culture has become…

For autologous T cell therapy to be effective, T cells sampled from a patient need to be grown in sufficient quantity before being injected back. The typical cell number required for an 80 kg patient is 8.109 cells. Achieving such a dose with T flasks, while maintaining cell health, poses logistical challenges that can become intractable when the number of patients rises. This is why the Xuriâ„¢ Cell expansion system W5, a rocking platform which enables automated high cell density…