Emergent CDMO
Provides contract development and manufacturing services for complex biological products, with in‑house capabilities for process development, analytical testing, drug substance production (including plasma-derived therapies), aseptic fill/finish, and handling of BSL2/BSL3 and other restrictive biologics. Offers customized CDMO partnership models and emphasizes quality, regulatory compliance and risk management across clinical and commercial stages.
Industries
Nr. of Employees
small (1-50)
Emergent CDMO
Gaithersburg, Maryland, United States, North America
Patents
Services
Process optimization, tech transfer and scale-up services including formulation development and product characterization to support progression toward clinical and commercial manufacturing.
Customized analytical development and testing across development phases to meet molecule-specific requirements.
Clinical-to-commercial manufacturing suites for plasma proteins, polyclonal antibodies and therapeutic proteins.
Robotic isolator-based aseptic filling for small- to mid-scale clinical and commercial batches, supporting vials, syringes and cartridges with integrated inspection, labeling and packaging.
Manufacturing services for BSL2/BSL3 and other restrictive biologics, including spore formers, live attenuated viruses and human and equine plasma products, with enhanced protective protocols.
Process optimization, tech transfer and scale-up services including formulation development and product characterization to support progression toward clinical and commercial manufacturing.
Customized analytical development and testing across development phases to meet molecule-specific requirements.
Clinical-to-commercial manufacturing suites for plasma proteins, polyclonal antibodies and therapeutic proteins.
Robotic isolator-based aseptic filling for small- to mid-scale clinical and commercial batches, supporting vials, syringes and cartridges with integrated inspection, labeling and packaging.
Manufacturing services for BSL2/BSL3 and other restrictive biologics, including spore formers, live attenuated viruses and human and equine plasma products, with enhanced protective protocols.
Expertise Areas
- CDMO contract manufacturing
- Bioprocess development and scale-up
- Aseptic fill/finish for sterile injectables
- Plasma-derived therapeutic manufacturing
Key Technologies
- Robotic isolator-based aseptic filling workcells
- Aseptic vial, syringe and cartridge filling
- BSL2 and BSL3 containment facilities and protocols
- Plasma protein manufacturing processes