Verdot's FlexiPro Chrom Platform Helps Address Bioprocessing Needs for Gene Therapy Manufacturing

Sebastien Lefebvre, MSc, the vice resident of R&D at Verdot
Credit: Verdot

Manufacturing of adeno-associated virus (AAV) vector-based gene therapy products is a complex and expensive process with many steps. As such, companies working on development and manufacture of gene therapy products are often looking for new tools to streamline their workflows.

At the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting, held May 7 to 10, 2024, in Baltimore, MD, CGTLive^® Verdot shared information about their FlexiPro™ Chrom platform, which is intended to address a variety of bioprocessing needs. After the conference, CGTLive® reached out to Sebastien Lefebvre, MSc, the vice resident of R&D at Verdot, to learn more.

CGTLive: Can you tell us a bit about yourself?

Sebastien Lefebvre, MSc: My name is Sebastien Lefebvre, and I am vice president of R&D at Verdot. I have over 32 years of experience across several related fields including biopharmaceutical, electronics, and custom industrial engineering. For the last 20+ years, I have worked at Verdot leading their product and application development programs. I hold 2 MSc degrees in Mechanical Engineering and Biology.

Can you give us some background information about Verdot?

Verdot is a bioprocessing technology company, specializing in downstream purification including chromatography and filtration. It was founded in 1950 to provide custom design and manufacturing for industrial applications. In the 1980’s we started to see a need for customized equipment from the emerging biopharmaceutical industry. In 1988, we developed the first chromatography columns with motorized axial compression. This started our long history of collaboration with biopharma and contract development and manufacturing organizations (CDMOs) that has continued to this day. We have over 35 years of experience in the design and manufacturing of tailored single- and multi-use purification technologies through sustainable engineering. We have a strong commitment to quality, security of supply, and sustainability.

At Verdot, we are a dedicated, close-knit team of bioprocessing engineers and scientists. Our headquarters and manufacturing facilities are in Riom, located right in the heart of France.

What is the FlexiPro platform and how is it unique?

The FlexiPro™ platform consists of our single-use good manufacturing practice (GMP) purification systems, including the FlexiPro™ Chrom and the FlexiPro™ TFF. One of the unique features of the platform is the interchangeable pump-head design, which enables a single system to cover multiple process scales.

I would say that the inspiration for the FlexiPro™ platform came from listening to our customers’ needs and translating those needs into an agile design. In 2015, we developed a precursor to the FlexiPro™ Chrom system that only offered 2 flow ranges, which were designed to meet the requirements for monoclonal antibody and vaccine workflows. During the following year, several customers with gene therapy applications commented that the system hardware met their requirements with precise flow control, the shallow linear gradient capabilities, and dual wavelength fraction collection; however, their applications required much smaller volumes and flow ranges. Leaning into our collaborative style, we added the Very Low Flow Kit with 1/8" ID tubing and the Ultra Low Flow Kit, with its 1/16” ID tubing capable of working with an 8mL column. The resulting design was the basis for the current FlexiPro™ Chrom system.

This multirange capability, enabling customers to scale up or down, or cover multiple steps, with 1 system, is what makes the FlexiPro™ platform unique. Let me quickly walk through a scenario using the FlexiPro™ TFF system: After harvest and clarification of AAV, the product will need to be concentrated, for example, from 1000 L down to 20 L. To accomplish this in an acceptable time (~5-6 hours), it will require a large filter and a high flowrate, let’s say 60 LPM. The FlexiPro™ TFF system with the Very High Flow Kit covers this need. Further downstream, after chromatography unit operations, the product may require buffer exchange before moving to fill-finish. The same FlexiPro™ system can be equipped with the Very Low Flow pump head in just a few minutes, enabling diafiltration with the Very Low Flow Kit which has a very small void volume.

The FlexiPro™ platform provides uncompromising performance since the same high level of precision flow rate control is maintained regardless of the flow kit used, and maintain accurate dilution and gradient control, and pressure control, for Chrom and TFF systems, respectively.

Offering a high-performance system is not sufficient if the flow kits can't be delivered on time. During the COVID-19 pandemic, we were able to deliver flow kits in a timely manner due to the strength of our supply chain, while our competitors’ delivery dates stretched out into many months. Today, we have set our supply chain targets to be able to deliver flow kits with a very short lead time.

True to our collaborative spirit and approach, our customers have direct access to our R&D and process automation experts, as well as their designated project manager. We often assist our customers during process development and the first GMP run to ensure their success.

This transcript has been edited for clarity.

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