53Biologics, a leading CDMO specializing in biologics production and cGMP manufacturing, is pleased to announce the opening of a new GMP production line for microbial-based products. The new production line features a 2,000 L fermenter, making it one of the largest of its kind in the world.
This new addition to the 53Biologics manufacturing facility expands the company’s capacity to meet the growing demand for microbial-based products and support more clients worldwide. In addition to the 2,000 L fermenter, the new GMP production line is equipped with a range of single-use downstream technologies, including chromatography systems, filtration units, and purification systems.
These technologies support the production of high-quality biologics with high yield and process efficiency. This capability is underpinned by rigorous process validation in biologics manufacturing, helping ensure that manufacturing processes consistently meet applicable quality and regulatory requirements.
“We are thrilled to add this new GMP manufacturing line to our existing capabilities for biologics production,” said Pablo Gutierrez, CEO of 53Biologics. “This investment not only expands our capacity to 2,000 L but also enhances our ability to deliver high-quality services to our clients. The larger volume of the fermenter enables us to scale up production for larger batches, which can result in cost savings for our clients. It also enables us to better meet the growing demand for microbial-based biotherapeutics, which is increasingly becoming the focus of the pharmaceutical industry.”
Learn more about how we approach scale-up manufacturing with quality and GMP compliance.
The installation marks another milestone in 53Biologics’ ongoing efforts to expand its service offerings and meet the evolving needs of the biologics industry. With this new addition, 53Biologics can support a wide range of clients, including organizations in the pharmaceutical, biotech, and academic sectors.
“We are excited about the new opportunities this 2,000 L fermenter brings to our company and our clients,” said Francisco Reyes, Business Development Manager at 53Biologics. “We remain committed to delivering superior quality services to our clients, and this new fermenter will help us achieve that goal.”
About 53Biologics
53Biologics is a CDMO with extensive experience in biologics production. The company offers a range of services for the biopharma industry, including process development, clinical manufacturing, and analytical testing to support biotherapeutics throughout development and toward commercialization.
For more information, contact Patricia De La Madrid, Marketing & Business Development Manager at 53Biologics, at pdelamadrid@53biologics.com.