| Listed site | cdmo | cdmo |
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| Summary | 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. | UK-based fill-finish CDMO offering rapid access to GMP aseptic manufacturing for clinical and commercial injectable drug products across mAbs, ATMPs, ADCs, RNA, peptides, vaccines, and small molecules. |
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| 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
- 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
| - Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Lyophilization (Freeze Drying)
- Secondary Packaging & Labeling
- Quality Control Testing
- CMC Analytical Development
- Formulation Development
- Process Development
- Cold-Chain Storage & Logistics
- Monoclonal Antibody (mAb) Manufacturing
- Recombinant Protein Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- mRNA Manufacturing
- Peptide Manufacturing
- Vaccine Manufacturing
- Viral Vector Manufacturing
- Cell Therapy Manufacturing
- Small Molecule Development & Manufacturing
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| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Vaccine
| - Biologics (Monoclonal Antibodies)
- Antibody-Drug Conjugate (ADC)
- mRNA
- Peptide
- Gene Therapy
- Cell Therapy
- Vaccine
- Small Molecule
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| Indications | Data not yet provided. | Data not yet provided. |
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| Locations | - 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
| - Headquarters, Stirling, United Kingdom
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| Certifications | - cGMP · Identifier: cGMP-compliant
- ISO · Identifier: ISO 14001
| - MHRA · Identifier: GMP Licensed
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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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