Charles River Announces Cell Therapy Manufacturing Capacity Expansion, Reinforcing Commitment to CDMO Clients

Rhea-AI Summary

Charles River Laboratories (NYSE: CRL) has expanded its cell therapy contract development and manufacturing facility in Memphis, Tennessee. The facility now includes nine new processing suites, enhancing its capacity for clinical and commercial cell therapy production. These suites maintain compliance with GMP and international standards, featuring advanced containment designs and high-volume production capabilities. This expansion follows the facility's EMA approval to produce allogeneic cell therapy products, enabling quicker commercialization of transformative medicines.

Positive

• Expansion adds nine state-of-the-art processing suites, increasing production capacity.
• Facility complies with GMP and international regulatory standards, ensuring high-quality manufacturing.
• EMA approval allows for the production of allogeneic cell therapy drug products.

Negative

• None.

Memphis CDMO facility sets the bar for clinical- and commercial-scale cell therapy production

MEMPHIS, Tenn.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced the expansion of its cell therapy contract development and manufacturing (CDMO) facility in Memphis, Tenn. The expanded space is suitable for clinical and commercial cell therapy manufacturing, with an additional nine (9) state-of-the-art processing suites, adding to an existing 16 cleanrooms.

The suites use advanced cleanroom facility technology and design to be fully compliant with current good manufacturing practices (GMP) and international regulatory standards, can accommodate flexible configurations to support client requirements, and are configured for high volume production, and options for dual production lines for late stage clinical- and commercial manufacture. The expansion incorporates full containment design of the suites, each with dedicated air handling to prevent cross-contamination, and templated two-dimensional modular construction for compliant flow of materials and personnel that minimizes risk to product, enabling repeatable results. Cleanrooms are fitted with key equipment, including centrifuges and incubators as standard, with client-specific, bespoke equipment available as required.

The Memphis CDMO facility expansion enables more cell therapy developers to streamline and accelerate their program(s) to commercialization with one partner, expanding access of needed transformative medicines to patients across the globe. This announcement follows the Memphis facility being named as the first CDMO in North America to receive EMA approval to commercially produce allogeneic cell therapy drug products. The newly built suites are online and available for reservation immediately.

Cell Therapy Manufacturing

The Memphis GMP CDMO facility supports the manufacture of clinical (early- and late-phase) as well as commercial cell and gene-modified cell therapies. With the 2021 acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences, Charles River significantly expanded its cell and gene therapy portfolio to include end-to-end CDMO capabilities (plasmid DNA, viral vector, and cellular therapies). These capabilities are fully integrated with Charles River’s legacy services resulting in a “concept-to-cure” cell and gene therapy portfolio.

Approved Quotes

• “This expansion builds on the Memphis site’s demonstrable expertise and commitment to supporting cell and gene therapy clients from early target identification through clinical and commercial-scale manufacturing. We look forward to continuing close partnerships with our clients and supporting projects to bring these potentially curative therapies to patients.” – Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River

• “This expansion marks another significant milestone met by our dedicated experts in Memphis, following our successful EMA inspection and GMP certification. We are incredibly proud of our industry leading team and facility in Memphis. We are excited for the opportunities this expansion will afford, as the industry has responded positively, with a meaningful portion of suites being already reserved.”–Will Isom, Site Director, Memphis, Charles River

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221107005053/en/

Investor Contact:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Media Contact:

Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

FAQ

What recent expansion did Charles River Laboratories announce?

Charles River Laboratories announced the expansion of its cell therapy contract development and manufacturing facility in Memphis, adding nine new processing suites.

How many total processing suites are now available at the Memphis facility?

The Memphis facility now has a total of 25 processing suites after the recent expansion.

What compliance standards does the Memphis facility meet?

The Memphis facility is compliant with current good manufacturing practices (GMP) and international regulatory standards.

What approval did the Memphis facility receive for cell therapy production?

The Memphis facility received EMA approval to commercially produce allogeneic cell therapy drug products.

What capabilities does the Memphis CDMO facility offer for cell therapy?

The facility supports the manufacture of clinical and commercial cell and gene-modified cell therapies.