CDMO Blog

Concentration and Reformulation of Cellular Immunotherapies – A Major Downstream Processing Step

An-image-of-the-GE-Sefia-Cell-Processing-SystemCellular immunotherapies (e.g. CAR-T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment, cells are expanded in volumes from 1-10 L. In the final step of downstream processing (DSP) for immunotherapies, cells cultured in large volumes must be concentrated and reformulated into smaller volumes (e.g. 20-100 mL) suitable for delivery to patients.

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Posted: Oct 30, 2019 3:48:28 PM

How To Scale-Up Lentiviral Vector Production Part 2: Considerations for Downstream Processing

Downstream Processing for LVV

In Part 1 of our series on lentiviral vector (LVV) manufacturing we covered scale-up of upstream processing steps. In this post we will look at the key steps in downstream processing (DSP). The industry “gold-standard” for recovery of purified and concentrated LVV is 10-20 percent. Improving on this low recovery is an opportunity to reduce the cost of manufacturing and get viral vectors into the hands of researchers who need them.

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Posted: Oct 30, 2019 1:57:46 PM

How to Scale-Up Lentiviral Vector Production Part 1: Considerations for Upstream Processing

Scientist working with bioreactor

Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. They are most often used to deliver genetic material that will modify cells and confer therapeutic properties. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. Scalable LVV production platforms are critical for manufacturing affordable cell and gene therapies and making them more widely available. For an overview of LVV manufacturing and process optimization considerations see our previous post.

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Posted: Oct 29, 2019 1:26:17 PM

What is a Bioreactor and How is it Used in Cell and Gene Therapy?

ccrm-cdmo-Bioreactors-500px

Simply put, a bioreactor is a stand-alone cell culture vessel enabled with sensors. Bioreactors differ fundamentally from traditional R&D cell culture in their ability to monitor and control key parameters such as temperature, pH, and dissolved oxygen (DO). Continuous, in situ monitoring of these parameters allow for a deep understanding of the growth environment of a given cell population -- creating avenues for process improvement. Paired controls enable dynamic, real-time responses as cells grow and the culture changes over time. With these capabilities, bioreactors can overcome limitations of traditional cell culture enabling the use of cell culture for commercial or clinical purposes.

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Posted: Oct 24, 2019 2:08:46 PM