| Listed site | cdmo | cdmo |
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| Summary | Sterile fill-finish CDMO for biologics, vaccines and ADCs, offering prefilled syringes, cartridges and vials across five US and European sites. It also supports oral solid dose manufacturing and drug substance development. | Simtra BioPharma Solutions is a CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and bioconjugation services for clinical and commercial products. |
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| Services | - Sterile Fill-Finish & Aseptic Manufacturing
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Vial Filling
- Lyophilization (Freeze Drying)
- Oral Solid Dosage Manufacturing
- Secondary Packaging & Labeling
- Combination Product Assembly & Final Packaging
- Stability Testing & Storage
- CMC Analytical Development
- Quality Control Testing
- Vaccine Manufacturing
| - 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
- Stability Testing & Storage
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Bioconjugation Services
- Vaccine Manufacturing
- Biologics Development & Manufacturing
- Small Molecule Development & Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- API Synthesis & Manufacturing
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| Modalities | - mRNA
- Vaccine
- Peptide
- Antibody-Drug Conjugate (ADC)
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Vaccine
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| Indications | Data not yet provided. | Data not yet provided. |
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| Locations | - Phoenix, Phoenix, USA
- Madrid, Madrid, Spain
- San Sebastián de los Reyes, San Sebastián de los Reyes, Spain
- Alcalá de Henares, Alcalá de Henares, Spain
- Granada, Granada, Spain
| - Bloomington, Bloomington, Indiana, USA
- Halle/Westfalen, Halle, Westfalen, Germany
- Headquarters, Bloomington, Indiana, USA
- Bloomington, Bloomington, Indiana, United States
- Headquarters, Bloomington, Indiana, United States
- Manufacturing, Halle/Westfalen, Germany
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| Certifications | Data not yet provided. | - cGMP · Identifier: cGMP-compliant
- ISO · Identifier: ISO 14001
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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