53Biologics is investing more than €2 million to add freeze-drying equipment at its manufacturing site in Boecillo, Spain. The expansion will allow the contract developer and manufacturer to offer an additional fill-and-finish step for biologic medicines that are difficult to keep stable in liquid form.
The new lyophilizer has 1.8 square meters of shelf space and can process up to about 10,000 2R vials per batch, according to the company. Lyophilization removes water from a frozen formulation under vacuum and can help preserve sensitive products when paired with a suitable formulation and process.
53Biologics has already used the equipment to make preclinical batches. It expects the service to be fully operational for manufacturing under current good manufacturing practice standards by early 2027.
The investment adds to filling capabilities at the Boecillo facility, which include an isolator, closed-system filling, semi-automatic filling and crimping, labeling and secondary packaging. The site also provides analytical testing, product release and storage at temperatures ranging from minus 80 degrees Celsius to room temperature.
The company said its fill-and-finish platform handles vial formats from 2R to 30R and supports batch sizes for orphan drugs and Phase 1 through Phase 3 clinical programs. Its services include work with plasmid DNA and recombinant proteins.
Chief Executive Pablo Gutiérrez said bringing freeze-drying in-house will let customers use the process alongside the company’s existing manufacturing services. For projects requiring equipment outside its facility, 53Biologics said it will continue to work with specialist partners.