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
Very Large (1000+)
Emergent CDMO
Gaithersburg, Maryland, United States, North America
Services
Process development, optimization and scale-up
Process optimization, tech transfer and scale-up services including formulation development and product characterization to support progression toward clinical and commercial manufacturing.
Analytical development and testing services
Customized analytical development and testing across development phases to meet molecule-specific requirements.
Drug substance manufacturing (plasma-derived and protein therapeutics)
Clinical-to-commercial manufacturing suites for plasma proteins, polyclonal antibodies and therapeutic proteins.
Aseptic fill/finish manufacturing
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.
Containment and restrictive-product manufacturing
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 development, optimization and scale-up
Process optimization, tech transfer and scale-up services including formulation development and product characterization to support progression toward clinical and commercial manufacturing.
Analytical development and testing services
Customized analytical development and testing across development phases to meet molecule-specific requirements.
Drug substance manufacturing (plasma-derived and protein therapeutics)
Clinical-to-commercial manufacturing suites for plasma proteins, polyclonal antibodies and therapeutic proteins.
Aseptic fill/finish manufacturing
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.
Containment and restrictive-product manufacturing
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