Simtra
Simtra Biopharma Solutions is a sterile product contract research and development and manufacturing organization with locations in Bloomington, IN, and Halle, North Rhine Westfallen, Germany. The capabilities of both sites are growing tremendously. Halle, Germany is developing a suite for conjugation and purification of antibody drug conjugates (ADCs) that is a multiproduct facility. It will be ready for GMP manufacturing during the first quarter of 2026 allowing for ADC DS/DP capabilities under one roof. In addition, there is a fully equipped laboratory for development of solutions and lyophilized solids that can be directly transferred to the manufacturing facility onsite. Solution formulations are examined rapidly to determine the best candidate for developing into a solution or into a lyophilized solid. Lyophilization process development is conducted using a design space approach for primary drying that directly benefits freeze-drying cycles for ADCs transferred to full-scale manufacturing. The majority of analytical testing methods, including cell-based methods, are available onsite for examining the product at laboratory-scale and for product release.
