| Listed site | cdmo | cdmo |
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| Summary | CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and ADC services across biologics, vaccines, and small molecules. | Sterile injectable CDMO specializing in fill-finish services for liquid and lyophilized vials, syringes, and cartridges, with Annex 1 compliant facilities and experience in biologics, small molecules, and vaccines. |
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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
- 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
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Lyophilization (Freeze Drying)
- Quality Control Testing
- Secondary Packaging & Labeling
- Serialization & Track-and-Trace
- Stability Testing & Storage
- CMC Analytical Development
- Technology Transfer
- CMC Regulatory Submission Support
- Controlled Substance Manufacturing
- Vaccine Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
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| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Vaccine
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Vaccine
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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
- Bloomington, Bloomington, Indiana, United States
- Headquarters, Bloomington, Indiana, United States
- Manufacturing, Halle/Westfalen, Germany
| - Headquarters, Grand Rapids, Michigan, United States
- Headquarters
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| Certifications | - cGMP · Identifier: cGMP-compliant
- ISO · Identifier: ISO 14001
| - GMP · Identifier: Five GMP manufacturing facilities
- Annex 1 · Identifier: Three facilities designed and qualified with Annex 1 revisions
- GMP · Identifier: Five GMP manufacturing facilities; three Annex 1 compliant
- FDA · Identifier: GMP
- EMA · Identifier: Annex 1
- GMP · Identifier: Five GMP manufacturing facilities (three Annex 1 compliant)
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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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