Simtra BioPharma Solutions
Sterile injectable development and manufacturing partner for complex biologics, vaccines, and small molecules.
Listed on cdmo.directory
CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and ADC services across biologics, vaccines, and small molecules. Headquartered in Bloomington, United States.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Synthetic chemistry infrastructure
- Capabilities
- HPAPI
Fill-finish formats
Regulatory clearances
Services
- Formulation Development
- Lyophilization (Freeze Drying)
- Technology Transfer
- CMC Analytical Development
- Sterile Fill-Finish & Aseptic Manufacturing
- Quality Control Testing
- CMC Regulatory Submission Support
- ADC (Antibody-Drug Conjugate) Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Bioconjugation Services
- Vaccine Manufacturing
- Biologics Development & Manufacturing
- Small Molecule Development & Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- API Synthesis & Manufacturing
About this organization
Overview
Simtra BioPharma Solutions is a dedicated contract development and manufacturing organization (CDMO) focused on sterile injectable products. The company offers comprehensive, customized services for clinical and commercial production of complex injectables.
Services & Capabilities
Development Services:
- Formulation development
- Lyophilization cycle optimization
- Technology transfer
- Analytical process development
- Pre-commercial development services
Manufacturing & Fill/Finish:
- Fill/finish operations
- Multi- and single-dose liquid vials
- Lyophilized vials
- Prefilled syringes
- Specialized containment for cytotoxics and highly potent compounds
Therapeutic Expertise:
- Cytotoxics
- Highly potent compounds
- Biologics
- Vaccines
- Small molecules
- Antibody-drug conjugates (ADCs) via strategic alliance with MilliporeSigma
Regulatory & Quality:
- Global regulatory support
- cGMP-compliant facilities
- ISO 14001-certified manufacturing practices
Strategic Partnerships
Simtra has formed a five-year strategic alliance with MilliporeSigma (Life Science business of Merck KGaA) to streamline ADC and bioconjugate development and manufacturing.
Facilities
Operations in the United States (Bloomington, Indiana) and Germany (Halle/Westfalen), with products distributed to more than 120 countries.
Certifications
Locations
Bloomington
Bloomington · Indiana · USA
Halle/Westfalen
Halle · Westfalen · Germany
Bloomington
Bloomington · Indiana · United States
Headquarters
Bloomington · Indiana · United States
Manufacturing
Halle/Westfalen · Germany
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