Aldevron is a biotechnology company that operates as a contract development and manufacturing organization, or CDMO. Founded in 1998, the company specializes in manufacturing high-quality biological materials for the pharmaceutical and biotech industries. Its primary role is to supply the foundational components needed to create advanced therapies and vaccines. Aldevron provides these services to support research, clinical trials, and the commercial production of new medical treatments.
Core Products and Services
Aldevron’s manufacturing is centered on three main categories of biological products: plasmids, messenger RNA (mRNA), and proteins. Plasmids are small, circular molecules of DNA that can be engineered to carry specific genetic information. They are often used as a starting point or a template in the production of more complex therapies.
The company also produces mRNA, which is a single-stranded molecule that carries genetic instructions from the DNA in a cell’s nucleus to its protein-making machinery. Aldevron synthesizes custom mRNA sequences for use in therapeutics and vaccines. Additionally, Aldevron manufactures a wide range of proteins, which are the functional molecules in cells that perform a vast array of tasks. These can be produced for therapeutic purposes or as enzymes and other reagents in research and manufacturing.
Aldevron adheres to strict manufacturing standards, most notably Good Manufacturing Practice (GMP). These quality systems ensure that the biological materials produced are pure, safe, and consistent enough to be used in human clinical trials and commercially approved medicines.
Role in Gene and Cell Therapy
The materials manufactured by Aldevron are fundamental to the progress of gene and cell therapies. In the field of gene therapy, which aims to treat diseases by correcting or replacing faulty genes, Aldevron’s plasmids are frequently used as the raw material to create viral vectors. These vectors, often adeno-associated viruses (AAV), are modified viruses that act as delivery vehicles, carrying therapeutic genes into a patient’s cells.
Similarly, these products are integral to cell therapies, such as CAR-T cell therapy for cancer. In this type of treatment, a patient’s own immune cells, known as T-cells, are extracted and genetically modified to recognize and attack cancer cells. Plasmids or other genetic vectors produced by Aldevron are used in the laboratory to insert a gene for a Chimeric Antigen Receptor (CAR) into the T-cells. These engineered cells are then infused back into the patient.
Contributions to Vaccine Development
Aldevron has also played a part in the development of modern vaccines, particularly those based on mRNA technology. The company is a major producer of plasmid DNA, which serves as the template for creating mRNA vaccines. In this process, the plasmid is engineered to contain the genetic sequence for a specific viral protein, such as the spike protein of the SARS-CoV-2 virus.
This plasmid DNA is then used in a cell-free enzymatic reaction to produce large quantities of mRNA. This resulting mRNA becomes the active ingredient in the vaccine. For example, during the COVID-19 pandemic, Aldevron supplied the linearized plasmid DNA template for Moderna’s COVID-19 vaccine, demonstrating the importance of a reliable supply chain for these components during a global health crisis.
The Danaher Acquisition and Industry Significance
In 2021, the growing importance of the biomanufacturing sector was highlighted when Danaher Corporation acquired Aldevron for approximately $9.6 billion. This acquisition was one of the largest in the sector. Danaher’s investment underscored the industry’s confidence in the future of gene therapies, cell therapies, and mRNA-based medicines.
The move also drew attention to the supply chain for these advanced therapies. The acquisition suggested that foundational biological materials from companies like Aldevron are components of the rapidly growing field of genomic medicine. It reflected a broader industry trend where manufacturing capabilities for these treatments are becoming as valuable as the therapies themselves.