BPI News: Scaling up Cell Therapy Discovery and Manufacturing with the Cloud

By Uduak Thomas

Cell and gene therapy development workflows are complex, multistep processes involving many moving parts and equipment that each generate unique data that needs to be collected, analyzed, and shared among people and systems in the lab. By linking cloud infrastructure directly to instruments in cell and gene therapy laboratories, Ganymede Bio and Kytopen intend to make it easier for Kytopen’s customers to capture data from instruments and access it in a structured way for cell therapy development and manufacturing.

The companies have signed an agreement to integrate Ganymede’s cloud platform with Kytopen’s FlowFect® cell therapy screening and manufacturing instruments. Ganymede provides a cloud-based infrastructure for integrating instruments and managing scientific data from the life sciences and manufacturing industries. The platform is a one-stop shop for creating code that connects instruments and software in the lab including electronic lab notebooks and lab information management systems, as well as captures, integrates, and manages data from these disparate systems.

Ganymede Bio was launched to provide cloud-based tools that could support wet lab data access and integration needs. Nathan Clark, Ganymede’s co-founder and CEO, noted in an interview that the company specifically targets wet labs because they are largely underserved from a software perspective. What Ganymede offers is a “broad-based cloud platform with all sorts of tools to help people connect and integrate things in the wet lab, manage their data, and build code and automation,” he told GEN. Essentially, Ganymede aims to take tasks that scientists routinely do in the wet lab and convert them to code that can be launched on command from the cloud.

Some of the platform’s components are a database for managing and moving information between systems as needed, and tools called agents that automatically pull information from lab systems directly into the cloud, among other tasks. One of the unique things about the platform is its Lab-as-Code tool. This application leverages the connections made with instruments and data to generate valuable business logic to optimize lab processes, control the flow of information between instruments and software, and provide scientists with valuable data to make program decisions and plan experiments.

Since its launch, Ganymede has worked with some smaller labs to connect equipment and software to its cloud. Ideally, labs that use the company’s platform will have people in-house who can write the code needed to implement and run tasks and processes. Labs that don’t have development expertise can take advantage of the company’s implementation and services team for coding help.

But Ganymede has its eyes set on the broader biomanufacturing and bioprocessing market. Specifically, the company plans to work with instrument providers like Kytopen to provide bespoke iterations of the platform designed for specific use cases like cell therapy development. Given the complexity of the data and lab processes involved in this space, Clark expects that over the next decade, more instrument providers will forge similar kinds of cloud partnerships for their systems either by partnering with Ganymede or other platform providers or even building the infrastructure themselves. For Ganymede, “cell and gene therapy is a great launching point because it’s so complex and really demands this level of integration and having the data in the cloud,” he said.

Founded about five years ago as a spinout from a Massachusetts Institute of Technology lab, Kytopen initially intended to commercialize microfluidics technology for transfecting bacteria but quickly pivoted to fill a perceived gap in the cell therapy market for large-volume, high-throughput systems. The company’s FlowFect platform provides products for delivering genome engineering materials in solution to cells using an electrical field. 

Kytopen’s portfolio includes Flowfect Discover, an automated small-volume liquid handling platform for smaller-scale transfection experiments that can be performed using 96-well plates with each well testing a different condition. Scientists use this system to optimize their cell therapies prior to scaling up with a second product, Flowfect Tx, a closed-system transfection instrument that delivers genetic payloads to billions of cells in minutes. Besides supporting cell therapy optimization and process development, Kytopen’s products have also found use in biologics development programs, gene therapies, cell line development, and viral vector manufacturing.

Bethany Grant, Kytopen’s CTO, explained that the partnership with Ganymede grew out of her company’s own need for better data management in their research initiatives. Kytopen continues to work on improving and developing the Flowfect suite of products in addition to running research initiatives in-house. “We recognized in our own development efforts that we could use a better data management system and came across Ganymede through a couple of connections,” Grant said in an interview with GEN. Rather than invest time and resources in developing a bespoke data management system, it made more sense to partner with an existing solution provider.  “They were exactly what we needed to keep track of data as it comes off our system and goes through flow cytometry and other analytical systems.”

The logical next step was to offer a similar kind of support to Kytopen’s users. The integration between the companies’ platforms means that Flowfect systems will push data from experiments directly to the cloud. And users will be able to launch experiments on their Flowfect systems from the cloud as well. “Building this strong data platform with the capabilities that Ganymede provides makes it easier for customers to know what they are getting and to have high confidence in the data they are getting and also connect it to downstream process analytics,” Grant noted.

The partners are in the process of integrating the platforms and expect to be ready to go to market soon. Both companies are also thinking through options for how Kytopen customers will access the Ganymede platform. “That’s something that we will iterate with the customers on but ultimately it’s whatever is smoothest for [them],” Clark said.

The post BPI News: Scaling up Cell Therapy Discovery and Manufacturing with the Cloud appeared first on GEN – Genetic Engineering and Biotechnology News.

manufacturing
cell therapy
gene therapy
biologics
life sciences
application
therapy