Research services firm Charles River Laboratories (CRL) says its burgeoning manufacturing business will use a “technology agnostic” strategy built around innovation and flexibility.

Drug research—primarily discovery and preclinical services but also human trials—has been CRL’s focus since it was founded in the late 1940s. However, in recent months the Wilmington, MA-based CRO has been building its manufacturing business.

In March, for example, CRL bought Cognate Bioservices and its subsidiary Cobra Biologics to add cell and gene therapy production capabilities and capacity. And in May, the company announced another acquisition in the production services space, unveiling a plan to buy gene therapy-focused CDMO Vigene Bioservices.

While it’s too early to go into specifics, Cognate and Vigene will redefine CRL’s manufacturing business in terms of the biopharma companies it works with and technologies it uses, according to Mike Austin, corporate vice president, global operations cell and gene therapy CDMO.

“The addition of their premier development and manufacturing capabilities to our existing expertise allows clients to bring their cell and gene therapies from early research and discovery all the way through commercialization in a single, streamlined program.”

He cites Cognate’s use of digital manufacturing technologies as an example, explaining, “The extent to which Cognate’s manufacturing operations are digitized is largely process and client dependent.

“We purposefully keep our operations technology agnostic, so the manufacturing process can be tailored to specific client needs: each client specifies which equipment they would like to use, leading to some being very closed and automated, while some are open and manual.”

Data management

The effective collation, management, and application of manufacturing process data is core to Cognate’s strategy, Austin says.

“Across the organization, Cognate has implemented a number of technologies to standardize and automate operations. We utilize an electronic documentation system, which also handles deviation and CAPA. In the labs there is an electronic LIMS system that produces the final Certificate of Analysis used in final batch release.”

Cognate built this infrastructure through partnerships. Last year, for example, it partnered with L7 Informatics to set up the enterprise scientific platform, a manufacturing information management system that is able to cope with multiple, complex projects.

“Due to the complexities associated with multi-product facilities and cell and gene manufacturing processes, Cognate required a bimodal, composable platform to provide both a flexible and comprehensive electronic solution,” says Austin, adding that  ESP’s model provides Cognate with the ability to host various CDMO workflows and adapt existing models to fit projects.

“We plan to leverage the L7 platform to enable Cognate’s digital twin; our real-time digital manufacturing process model to apply machine learning and data science methods to self-optimize, self-correct, and automate our manufacturing operations,” he notes.

Supplier relations

CRL will also leverage relationships with suppliers to try and make sure its manufacturing business is able to cater to the full range of customer demands.

Austin says, “Innovative manufacturing technologies are driven through relationships with key suppliers, largely through the use of existing tools and processing systems and working together to develop new technologies to address outstanding challenges.”

He cites Cognate’s partnerships—through Cobra Biologics—with bioprocessing systems firm Cytiva and its viral vector-focused deal with Pall as examples of how the firm monitors innovation.

“We keep up to date through these long-term relationships with key suppliers, scientific publications and, when possible, attendance of scientific meetings. As an organization, we will perform proof-of-concept work with our partners to make strategic, informed recommendations on how our clients should set up their processes.”

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