Simtra BioPharma Solutions

Overview

Simtra BioPharma Solutions is a contract development and manufacturing organization (CDMO) dedicated to developing and manufacturing quality sterile injectable products. The company operates cGMP-compliant, ISO 14001-certified facilities in Bloomington, Indiana, USA, and Halle/Westfalen, Germany, serving clients across more than 120 countries.

Services

Simtra offers a comprehensive range of integrated services for parenteral products:

• Formulation Development — customized formulation and reformulation for injectable products
• Lyophilization Cycle Development and Optimization — specialized freeze-drying expertise
• Rapid Technology Transfer — streamlined process transfer from development to manufacturing
• Fill/Finish Operations — liquid vials, lyophilized vials, and prefilled syringes
• Specialized Containment — handling of cytotoxic, highly potent compounds, and other specialized drug categories
• Analytical Services — analytical method development and quality control
• Global Regulatory Support — regulatory guidance and compliance across markets

Therapeutic Expertise

Simtra has deep scientific expertise across multiple drug categories including cytotoxics, highly potent compounds, biologics, vaccines, small molecules, and diluents. The company is expanding upstream capabilities through bioconjugation services, creating an integrated drug substance to drug product solution.

Facilities & Capacity

Both facilities are award-winning, cGMP-compliant operations using state-of-the-art equipment. Simtra recently announced a strategic purchase of a 65-acre property with over 300,000 square feet of available expansion space near its Bloomington facility, and completed construction of a new production building at its Halle, Germany campus.

Strategic Partnerships

Simtra has formed a five-year strategic alliance with MilliporeSigma (Life Science business of Merck KGaA) for antibody drug conjugate (ADC) drug substance and drug product manufacturing services.