| Listed site | cdmo | cdmo |
|---|
| Summary | CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and ADC services across biologics, vaccines, and small molecules. | CDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management. |
|---|
| 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
| - CMC Analytical Development
- Formulation Development
- Process Development
- Technology Transfer
- API Synthesis & Manufacturing
- HPAPI Manufacturing (High-Potency)
- Controlled Substance Manufacturing
- Peptide Manufacturing
- ADC Payload & Linker Synthesis
- ADC (Antibody-Drug Conjugate) Manufacturing
- Oral Solid Dosage Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- Vaccine Manufacturing
- Biologics Development & Manufacturing
- Recombinant Protein Manufacturing
- Bioconjugation Services
- Monoclonal Antibody (mAb) Manufacturing
- CMC Regulatory Submission Support
|
|---|
| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Vaccine
| - Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Peptide
- Vaccine
|
|---|
| Indications | Data not yet provided. | Data not yet provided. |
|---|
| Locations | - Bloomington, Bloomington, Indiana, USA
- Halle/Westfalen, Halle, Westfalen, Germany
- Bloomington, Bloomington, Indiana, United States
- Headquarters, Bloomington, Indiana, United States
- Manufacturing, Halle/Westfalen, Germany
| - Grangemouth, Grangemouth, Scotland, United Kingdom
- Shanghai, Shanghai, China
- Sourcing Office, Shanghai, China
|
|---|
| Certifications | - cGMP · Identifier: cGMP-compliant
- ISO · Identifier: ISO 14001
| - MHRA · Identifier: GMP Certificate
- GMP · Identifier: GMP
- ISO · Identifier: ISO 9001, 14001, 45001
- FAMI-QS · Identifier: FAMI-QS
- ISO · Identifier: ISO 9001
- ISO · Identifier: ISO 14001
- ISO · Identifier: ISO 45001
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|