CDMO Blog

Viral Aggregation in Downstream Processing of Lentiviral Vectors

Beckman Coulter CytoFLEX Flow Cytometer credit CCRM 500 px wideViral vectors are vehicles for delivery of therapeutic DNA in cell and gene therapies. With over 1,000 cell and gene therapy (CGT) clinical trials underway globally, there is a growing need to address challenges in viral vector manufacturing – both upstream and downstream. In a previous post, we outlined the key steps in downstream processing (DSP) for the manufacturing of lentiviral vectors (LVV). Achieving high concentration without aggregation is a significant technical bottleneck in manufacturing LVV. In this post, we will explore the concept of viral aggregation and its influence in every step of DSP for LVV.

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Posted: May 11, 2020 10:57:59 AM

Considerations for the Use of Stable Producer Lines in the Manufacturing of Lentiviral Vectors

A-cell-culture-plate-is-handled-by-a-scientist

In an introductory post on lentiviral vector (LVV) manufacturing for cell and gene therapies (CGTs) we touched upon the challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.

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Posted: Oct 30, 2019 3:04:35 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 the Best Way to Manufacture Lentiviral Vectors for Cell and Gene Therapies?

Cytiva GE Xcellerex XDR 10L Bioreactor

In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. AAVs are most commonly used to deliver gene therapies – meaning they will be administered directly to a patient. In contrast, LV is typically used as an input material to genetically modify cells used for cell therapies (e.g. CAR-Ts) and is not included in the final product delivered to the patient.

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Posted: Sep 5, 2019 9:01:23 PM