Simtra BioPharma Solutions
Sterile injectable development and manufacturing partner for complex biologics, vaccines, and small molecules.
Sterile injectable CDMO specializing in formulation development, lyophilization, fill/finish, and ADC manufacturing with cGMP-compliant facilities in the U.S. and Germany. Headquartered in Bloomington, United States.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Manufacturing (M)
Synthetic chemistry infrastructure
- Capabilities
- HPAPI
Fill-finish formats
Regulatory clearances
Services
- Formulation Development
- Lyophilization (Freeze Drying)
- Technology Transfer
- Sterile Fill-Finish & Aseptic Manufacturing
- CMC Analytical Development
- CMC Regulatory Submission Support
- Prefilled Syringe (PFS) Filling
- Vial Filling
- ADC (Antibody-Drug Conjugate) Manufacturing
- Vaccine Manufacturing
- HPAPI Manufacturing (High-Potency)
- Biologics Development & Manufacturing
- Stability Testing & Storage
- Bioconjugation Services
- Process Development
- Quality Control Testing
- Small Molecule Development & Manufacturing
- API Synthesis & Manufacturing
About this organization
Simtra BioPharma Solutions is a dedicated sterile injectable development and manufacturing partner offering comprehensive, customized services for clinical and commercial production. The company specializes in formulation development, lyophilization cycle optimization, technology transfer, analytical method development, fill/finish operations, and specialized containment capabilities.
Service Capabilities:
- Formulation development and process development for complex sterile injectables
- Lyophilization cycle optimization
- Fill/finish operations supporting multiple delivery formats: multi- and single-dose liquid vials, lyophilized vials, and prefilled syringes
- Analytical method development and quality control
- Technology transfer and regulatory support
- Specialized expertise in cytotoxics, highly potent compounds, biologics, vaccines, small molecules, and diluents
Strategic Partnerships: Simtra has formed a five-year strategic alliance with MilliporeSigma (Merck KGaA Life Science business) to streamline ADC and bioconjugate development and manufacturing, enabling integrated end-to-end services.
Operations: The company operates cGMP-compliant facilities in Bloomington, Indiana and Halle/Westfalen, Germany, with ISO 14001-certified manufacturing practices. Products manufactured are distributed to more than 120 countries. Simtra is actively expanding U.S. capacity with a recent strategic property purchase near its existing Bloomington facility.
Certifications
| Authority | Identifier | Source |
|---|---|---|
| ISO | ISO 14001 | View |
Locations
Bloomington
Bloomington · Indiana · USA
Halle/Westfalen
Halle · Westfalen · Germany
Bloomington
Bloomington · Indiana · United States
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