Simtra BioPharma Solutions
Sterile injectable development and manufacturing partner for complex biologics, vaccines, and small molecules.
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
Related companies
Similar profiles by shared services, modalities, and capabilities.
Simtra BioPharma Solutions- Formulation Development
- Lyophilization (Freeze Drying)
Grand River Aseptic Manufacturing- Lyophilization (Freeze Drying)
- Technology Transfer
Pfizer CentreOne- Formulation Development
- Lyophilization (Freeze Drying)
Samsung Biologics- Formulation Development
- Lyophilization (Freeze Drying)
- BSP Pharmaceuticals
- Formulation Development
- Lyophilization (Freeze Drying)
Carbogen Amcis- Formulation Development
- Lyophilization (Freeze Drying)
Piramal Pharma Solutions- Formulation Development
- Technology Transfer
Dr. Reddy's Laboratories- Formulation Development
- Technology Transfer
Submit a verified review for this organization.
Markdown mirror: /companies/baxterbiopharmasolutions.md