Manufacturing
Manufacturing
CGMP Manufacturing
Cytovance® provides a state-of-the-art, full-service manufacturing solution. We provide CGMP manufacturing, process development, and manufacturing support. Our manufacturing services include:
- CGMP Mammalian Manufacturing up to 2,000L
- CGMP Microbial Manufacturing up to 1,000L
- CGMP cell banking (microbial and mammalian)
- Flexible and Customized GMP Manufacturing
- R&D, Cytograde™ and CGMP Grade Plasmid Manufacturing
Cytovance occupies 140,000 sq. ft. of manufacturing space. This includes segregated Mammalian, Microbial, and Flex manufacturing suites with an independent state-of-the-art warehouse. All of these facilities are custom designed for multiproduct CGMP production of biopharmaceuticals.
Our 50,000 sq. ft. mammalian facility features production in cell culture suites utilizing single-use bioreactorsat 250L, 1,000L and 2,000L scale and stainless-steel bioreactors at 500L scales. Recovery and purification are undertaken in adjacent independent purification suites. An adjacent facility houses process development and analytical development laboratories, and administrative offices. Microbial manufacturing capabilities include CGMP fermentation processes at 10L, 200L, 300L and 1,000L scales and downstream recovery process suites with 2 x 5,000L refolding tanks.
Cytovance houses all client inventory within two warehouse facilities. These temperature-monitored facilities suitable for GMP storage include a main warehouse of 36,000 sq. ft. and a secondary warehouse of 22,000 sq. ft. Cytovance enforces strict batch control practices and total compliance to expiration policy. Within the main warehouse is a walk-in cool room with refrigerator temperature of 2-8 degree Celsius (36-46 degree Fahrenheit). There are also several freezers with temperature maintained between -25 to -10 degree Celsius (-13 to 14 degree Fahrenheit). The facility’s ultra-low temperature freezers allow for storage below -55 degree Celsius (-67 degree Fahrenheit).
Cytovance also has dedicated pDNA microbial development labs and CGMP cleanrooms that support single-use fermentation technologies at 30L and 300L scales with integrated processing and in-house product release testing. This dedicated pDNA platform allows us to rapidly initiate client projects and fulfill orders in compliance with all regulatory requirements.
