home > news > detailed info

Pioneering a New Era of Cell Therapy Manufacturing

Charles River

Memphis facility becomes first North American CDMO to receive EMA approval for commercial allogeneic cell therapy production

Aug 09 2022: Following its successful inspection, our Memphis cell therapy manufacturing facility is paving the way in the cell and gene therapy industry as the first contract development and manufacturing organization (CDMO) in North America to be awarded a commercial GMP license to produce allogeneic cell therapy drug products from the European Medicines Agency (EMA).

“We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy,” commented Birgit Girshick, CEVP & COO, in a press release announcing the news. “We are looking forward to continuing a close partnership with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.”

Cell Therapy Development and Manufacture

Our allogeneic (donor cells) and autologous (patient’s own cells) comprehensive cell therapy manufacturing portfolio of services includes GMP production of cells from a variety of starting materials including immune cell populations (such as T-cells, NKs, Dendritic cells) and stem cells. Our experienced team is well-versed in supporting clients through the development pathway, optimizing development protocols, and securely and swiftly scaling up production from clinical to commercial scale.

Located right next to the largest logistics hub in North America, the Memphis site, purpose-built for GMP cell and gene-modified cell therapy production, was integrated into Charles River’s comprehensive cell and gene therapy portfolio in 2021, with the acquisition of established CDMOs Cognate BioServices and Cobra Biologics.

“Our team in Memphis has worked extremely hard to successfully complete the EMA inspection and authorization process,” remarked Will Isom, Memphis site director. “We are excited to be the first CDMO in North America to reach this milestone.”
phone +1.877.CRIVER.1
email Charles River Laboratories International, Inc. 251 Ballardvale Street Wilmington, MA 01887
Print this page
Send to a friend
News and Press Releases

Quinten Health Closes its Financing Round to Advance Disease Modelling Platforms and Virtual Twins in Real-World

Paris, September 21st, 2022 – Life Science Newswire – QUINTEN HEALTH, a pioneer in real-world data science, Artificial Intelligence (AI) and Machine Learning (ML) for precision care, today announces that it has closed its financing round to advance disease modeling platforms and virtual twins in real-world, as part of the Quinten Group's €14 million growth equity investment from TECHLIFE CAPITAL and MACSF, essentially dedicated to the healthcare activities of the Quinten group.
More info >>

White Papers

Mouse Models for Evaluation of Vaccines and Therapeutics Against Staphylococcal Infections

IBT Bioservices

Introduction Staphylococcus aureus (SA) is a ubiquitous, formidable Gram-positive pathogen associated with skin and soft tissue, as well as lifethreatening systemic infections. SA is a leading cause of hospital- and community-associated infections worldwide, affecting humans and animals. The wide range of pathologies reflects the diverse abilities of this microbe to escape the innate and adaptive immune response using virulence factors. Since its first emergence in the 1960s methicillin-resistant SA (MRSA) has become endemic in hospitals and healthcare settings worldwide. In the 1990s, community associated MRSA strains (CA-MRSA) emerged, and are spreading worldwide posing a major global challenge.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement