June 1, 2021 /NewsDesk/

Research services firm Charles River Laboratories (CRL) states that its fast-growing manufacturing business uses a technology-agnostic strategy built around innovation and flexibility.

Since its founding in the late 1940s, CRLs have primarily provided drug discovery and preclinical services, but also focused on human clinical trials. However, in recent months, the Wilmington, Massachusetts-based CRO is building a manufacturing business.

For example, in March CRL acquired Cognate Bioservices and its subsidiary Cobra Biologics, adding capacity and capacity for cell and gene therapy. And in May, the company announced another acquisition in the production services sector, revealing plans to acquire CDMO Vigene Bioservices, which specializes in gene therapy.

It’s too early to elaborate, but Cognate and Vigene will redefine their CRL manufacturing business in terms of the technology they use with their partner biopharmacy companies, the corporate vice of global operations cells and gene therapy CDMO. President Mike Austin said.

By adding top-notch development and manufacturing capabilities to our existing expertise, our customers offer cell and gene therapy in a single streamlined program, from early research and discovery to commercialization. can do.

He uses Cognates’ digital manufacturing technology as an example. The degree to which Cognates manufacturing operations are digitized is highly process and client dependent.

We deliberately remain operational technology agnostic, allowing the manufacturing process to be tailored to the needs of a particular client. Each client specifies the equipment they want to use, some are very closed and automated, some are open and manual.

Data management

Effective matching, management, and application of manufacturing process data is at the core of Cognates’ strategy, Austin says.

Throughout the organization, Cognate implements a number of technologies for standardizing and automating operations. We use an electronic documenting system to handle deviations and CAPA. The lab has an electronic LIMS system that creates the final analysis certificate used in the final batch release.

Cognate built this infrastructure through a partnership. Last year, for example, the company partnered with L7 Informatics to launch the Enterprise Scientific Platform, a manufacturing information management system that can handle multiple complex projects.

Due to the complexity associated with multi-product facilities and cell and gene manufacturing processes, Cognate needed a bimodal, configurable platform that offered both flexible and comprehensive electronic solutions, Austin said. He added that he would provide Cognate with the ability to host a variety of CDMOs, tailoring the workflow and adapting the existing model to the project.

We plan to leverage the L7 platform to enable Cognates digital twins. He points out that a real-time digital manufacturing process model that applies machine learning and data science techniques to self-optimize, self-correct, and automate manufacturing operations.

Supplier relationship

CRLs also leverage their relationships with suppliers to ensure that their manufacturing operations meet all customer demands.

Austin has innovative manufacturing technologies, primarily using existing tools and processing systems, through relationships with leading suppliers by working together to develop new technologies to address open challenges. Will be promoted.

He cites Cognates’ partnership with Cobra Biologics and bioprocessing systems company Cytiva, as well as a viral vector-focused deal with Pall as an example of how the company monitors innovation.

We stay up to date through long-term relationships with major suppliers, scientific publications, and, if possible, attendance at scientific conferences. As an organization, we work with partners to proof-of-concept and make strategic, informed recommendations on how clients should configure their processes.

 Original Article