A Decade of Scalable Excellence in Cell and Gene Therapy Manufacturing by Cellex

Celebrating a Decade of Excellence in Cell and Gene Therapy Manufacturing

Over the past decade, Cellex Cell Professionals has established itself as a leader in cell and gene therapy (CGT) manufacturing, marking significant milestones and expanding its manufacturing capabilities. Founded in 2001 by Professor Gerhard Ehninger in Dresden, Germany, Cellex was created with the aim of providing vital cellular therapies to patients in need of hematopoietic stem cell transplants. Today, with more than ten years in the field, the company operates as a full-service Contract Development and Manufacturing Organization (CDMO) dedicated to CGT.

Strategic Growth and Facility Expansion

The company’s journey began with a focus on patient access and operational excellence. In 2009, Cellex expanded its reach by opening a second collection center in Cologne, which has since performed over 50,000 cell collections. This strategic move allowed the company to fortify its ability to support the entire value chain of CGT manufacturing. Alongside this expansion, Cellex ensured the reliable global transportation of over 20,000 shipments, further solidifying its comprehensive manufacturing capabilities.

Since 2019, Cellex has undertaken three major upgrades to its GMP-compliant infrastructure, integrating high-performance cleanrooms and quality control laboratories. The latest expansion increased its GMP-certified manufacturing area to over 2,500 square meters, which includes 37 cleanroom workstations designed to enhance production efficiency.

A Proven Track Record of Manufacturing

With more than 5,800 batches of CGT/ATMP produced — comprising over 1,300 clinical products and more than 4,500 commercial goods — Cellex has consistently demonstrated its operational maturity and the trust placed in it by industry partners. Currently, the company is involved in the production of six final pharmaceutical products and seven cellular intermediates, supporting the commercial production of three CAR-T therapies recognized in the EU. Notably, in 2023, Cellex became known for manufacturing Europe’s first allogenic CAR-T product, further establishing its position as a pioneer in advanced therapeutic solutions.

According to Carla Kreissig, CEO and Chief Medical Officer of Cellex, "The milestone of producing over 5,800 batches showcases not only the scale but also the refined maturity of our processes and the confidence of our partners. With the recent expansion of our GMP facilities, we further enhance our capabilities to meet the rising demand and ensure ongoing excellence.”

New Standards for Quality Control

As part of its commitment to quality, Cellex also recently unveiled a new materials storage warehouse built to the highest standards to ensure the quality, safety, and efficiency of each batch produced. This expanded storage capacity allows Cellex to better serve the increasing demand for CGT manufacturing.