Cytovance® Biologics is a preferred CDMO for large molecule API manufacture due to its depth of operational experience in both mammalian and microbial based platforms. Since 2005, Cytovance has worked on 70+ unique large molecule APIs supporting 20+ disease areas. Cytovance is well known to be responsive to client needs, reliable on timelines and resourceful in addressing some of the industry’s most complex biomanufacturing challenges.
Cytovance’s many clients find an exceptional partnering philosophy that assures long term support of clinical API supply chain.
Cytovance’s combination of clean regulatory inspection history and state-of-the art facilities has moved us into the realm of commercial API manufacturing. We have a growing list of future commercial products (with filed BLAs) pending regulatory approval. Cytovance is one of the best CDMOs for partnering to provide a fully integrated pathway, from expression vector construction, process development and characterization, pilot production and manufacture supporting the entire lifecycle of biologics development.
State-of-the-art Facilities Feature Single-Use and Stainless Options
Cytovance’s 23,000 square feet of cleanroom manufacturing space is custom-designed for cost effective multi-product cGMP manufacturing. Each manufacturing area is designed to meet global regulatory standards.
Our Mammalian facility features 10,000 square feet of cleanroom cell culture suites utilizing single-use bioreactors at 250L, 1,000L, and 2,000L scale and stainless-steel bioreactors at 100L and 500L scales. Recovery and purification is undertaken in adjacent independent purification suites. We also have suites segregated for pre- and post-viral operations.
Cytovance’s “flex” facility houses two unique cGMP manufacturing suites intended to produce specialized therapeutic products. These “flex” suites can quickly be reconfigured to run a variety of different biologics platforms. This facility also houses a 200L microbial suite as well as process and analytical development laboratories.
Cytovance’s new microbial facility hosts a 10L, 300L SUF and 1,000L(w/v) fermenters with all applicable cell processing equipment. We will have additional 200L SS capacity that will be available in 2019. The downstream process recovery suites feature 2 X 5,000L imPULSE mixers for refolding with independent purification suites.
Cytovance recently commissioned a new custom designed 30,000-square-foot standalone cGMP warehouse that is temperature controlled, has a raw material sampling area and classified cleanroom dispensing areas. Early in 2018, we passed a PLI inspection with the FDA to support a clinical product launch with zero 483s and now is certified to manufacture its first commercial product.
R&D Services
Manufacturing
- Cell Line Development
- Keystone Expression System® for E. coli
- Cell Culture Process Development
- Microbial Fermentation Development
- Pre-Formulation Stability Testing
- Recovery & Purification Development
- Purification Development
- Process Transfer
- Analytical Method Transfer, Development & Qualification
- Process Characterization Services
- Cell Culture
- Microbial Fermentation
- Harvest & Recovery
- Large-scale Refold
- Purification & Separations
- Customized DS Manufacturing
- Microbial & Mammalian Cell Banking
- Process Validation
Support Services
- Project Management
- Quality Control Testing
- Analytical Method Validation
- Stability Testing
- Raw Materials Management