| Listed site | cdmo | both |
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| Summary | Small molecule CDMO offering comprehensive API development and manufacturing from discovery through commercial cGMP production, with specialized expertise in complex and hazardous chemistries and ADC bioconjugation. | Global leader in carbohydrate and glycan synthesis, offering custom synthesis, CRO, and CDMO services for drug discovery and development. Specializes in GalNAc targeting ligands, glycopeptides, and glycoconjugates with over 25 years of expertise. |
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| Services | - API Synthesis & Manufacturing
- HPAPI Manufacturing (High-Potency)
- Controlled Substance Manufacturing
- Peptide Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- ADC Payload & Linker Synthesis
- Flow Chemistry & Continuous Manufacturing
- Solid-State Chemistry & Polymorph Screening
- CMC Analytical Development
- Process Development
- CMC Regulatory Submission Support
- Bioconjugation Services
- Small Molecule Development & Manufacturing
- Quality Control Testing
- Technology Transfer
| - API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Process Development
- CMC Analytical Development
- Technology Transfer
- Bioconjugation Services
- Translational Research
- Discovery Research
- Quality Control Testing
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| Modalities | - Small Molecule
- Peptide
- Antibody-Drug Conjugate (ADC)
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Vaccine
- Peptide
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| Indications | Data not yet provided. | - Oncology
- Infectious Disease
- Immunology
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| Locations | - Cork, Cork, Munster, Ireland
- Cramlington, Cramlington, Northumberland, United Kingdom
- Deeside, Deeside, Wales, United Kingdom
- Newcastle Biosphere, Newcastle, Tyne and Wear, United Kingdom
- North Carolina, North Carolina, North Carolina, United States
- Wisconsin, Wisconsin, Wisconsin, United States
- North Carolina, North Carolina, North Carolina, US
- Wisconsin, Wisconsin, Wisconsin, US
- Newcastle Biosphere, Newcastle, England, UK
- North Carolina, North Carolina, US
- Wisconsin, Wisconsin, US
- Cramlington, Cramlington, England, UK
- North Carolina, North Carolina, North Carolina, USA
- Wisconsin, Wisconsin, Wisconsin, USA
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| Certifications | - FDA · Identifier: cGMP inspection
- HPRA · Identifier: cGMP inspection (mutually recognised by FDA)
- PMDA · Identifier: Project specific inspection
- ANVISA · Identifier: Project specific inspection
- MHRA · Identifier: cGMP inspection
- DEA · Identifier: Schedule I-V controlled substances approval
- ISO · Identifier: ISO/IEC 27001:2022, ISO/IEC 9001:2015, ISO 45001:2018, ISO 14001:2015
- FDA · Identifier: cGMP inspection January 2017
- PMDA · Identifier: project specific inspection June 2022
- HPRA · Identifier: cGMP inspection March 2022
- ANVISA · Identifier: project specific inspection 2021
- MHRA · Identifier: cGMP inspection June 2021
- FDA · Identifier: cGMP inspection May 2018
- MHRA · Identifier: cGMP inspection April 2023
- FDA · Identifier: Registered as bulk API manufacturer
- DEA · Identifier: Approved to import, store, manufacture and export Schedule I-V controlled substances
- FDA · Identifier: cGMP inspection March 2024
- cGMP · Identifier: cGMP accreditation
| - ISO · Identifier: ISO 9001:2015
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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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