- 53Biologics is investing more than €2 million in infrastructure at its Boecillo site in Spain to add lyophilization capacity for sensitive therapeutics.
- The new 1.8 m² lyophilization system will expand fill-and-finish capacity to approximately 10,000 2R vials per batch and is expected to be fully operational for cGMP manufacturing by early 2027.
53Biologics, a European contract development and manufacturing organization (CDMO), is investing more than €2 million to expand infrastructure at its Boecillo, Spain facility. The investment adds freeze-drying, or lyophilization, capabilities to support the handling of next-generation therapeutics and expands the company’s in-house fill-and-finish offering.
The new 1.8 m² lyophilization system at the company’s cGMP facility will enable processing of liquid and lyophilized presentations. It will support batches of up to approximately 10,000 2R vials and bring an additional manufacturing step in-house for biologic medicines that are difficult to maintain in liquid form.
The equipment has already been used to produce preclinical batches for development work before human trials. 53Biologics expects the new service to be fully operational for cGMP manufacturing by early 2027. The expansion follows the company’s recent additions of filling, crimping, labeling, secondary packaging, and analytical capabilities.
The company said the lyophilization expansion is part of its broader approach to providing pharmaceutical and biotechnology customers with development and manufacturing services through a single point of contact. Where requirements fall outside its internal capabilities, 53Biologics works with specialized partners to provide additional fill-and-finish support.
“Adding lyophilisation to our in-house fill & finish capabilities is an important step in the evolution of 53Biologics’ service offering. We are investing in the areas that matter most to our customers, ensuring that we can confidently meet the industry’s changing clinical and regulatory demands when it comes to the next generation of drug manufacturing.”
Pablo Gutiérrez, CEO of 53Biologics
