scientific methodologies in high throughput process development
annual programs ranging from FIH process development to late-stage process development, characterization & validation
IND submissions supported annually
Cell culture process development activities at KBI cover the full development cycle, from supporting early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies.
The KBI team has worked with protein production processes at all scales from laboratory, pilot and clinical scales to commercial scales up to 2000L. We have characterized mixing conditions in bioreactors from ambr15 to 2000L scale. In depth understanding of the impact of agitation, aeration, and working volume at each scale has allowed us to tech transfer in wide variety of processes very successfully.
KBI has been a pioneer in integrating new and cutting edge technologies into our process development platform. For example, use of high throughput miniaturized bioreactors and associated analytics for process optimization and characterization, ATF based high cell density processes, and targeted optimization of product quality attributes are services offered at KBI.
The KBI CCPD team has experience with over 15 different mammalian cell line vendors. The nuances about the different cell line platforms allows us to develop high productivity, robust, and scalable processes within an expedited timeline. In addition to standard mAbs, KBI has extensive experience in developing Fc-fusion proteins, bi-specific antibodies, growth factors, enzymes, vaccine glycoproteins, PEGylated proteins, and other glycoproteins.
Our unwavering customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients.
Robust, reproducible, and scalable processes using cell lines from more than fifteen cell line platforms from across the globe as well as with KBI’s internal cell lines
In-depth knowledge about vendor cell line platforms and ability to deliver the best possible output from a cell line
Platform cell culture processes for our internal cell line systems
Ability to rapidly deliver IND enabling Toxicology material
Learn more: Case Study | Improving Titer
Miniaturized bioreactors through the ambr platform (ambr15 and ambr250)
High throughput chromatographic screening capabilities (TECAN FREEDOM EVO)
Complementary analytics (Octet QK384, Caliper LabChip GXII, and Cedex BioHT)
Cost reduction of material and resources through the use of these technologies in process characterization studies
Data from over 30 molecules from bench scale to 200-2000L
Extensive mixing charactarization studies at all scales
Scale up of high cell density culture using ATF
Accelerated development using in-house scalability data across cell line and process type
Learn more: Case Study | High Cell Density Process
Successful delivery of a large number of biosimilar programs
Well versed in using multiple lots of innovator product to set ranges to drive clone selection and process optimization
Proven record of best in class process development
Control of product quality through use of process parameters and supplements
Ability to provide extensive reactor characterization studies across all scales starting from ambr250 to the 2000L disposable bioreactor
Qualification of scale down models for wide range of bioreactor systems
Advanced process control tools and strategies
Application of QbD princeples to late stage development
Use of PAT for improved process control