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Cell Culture

Cell culture process development supporting the full development cycle

Unwavering Customer Focus and Situational Flexibility

From Early-Stage Discovery to GMP Manufacturing

 

Our unwavering customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients.

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 Ambr® 15 to 2000L scale. An in-depth understanding of the impact of agitation, aeration, and working volume at each scale has allowed us to successfully tech transfer in a wide variety of processes.

KBI has been a pioneer in integrating new and cutting-edge technologies into our process development platform. For example, the use of high throughput miniaturized bioreactors and associated analytics for process optimization and characterization intensified upstream process, and targeted optimization of product quality attributes are services offered at KBI.

The KBI upstream PD team has experience with over 15 different mammalian cell line vendors. The nuances of the different cell line platforms allow 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.

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KBI’s Cell Culture Process Development Capabilities

Expedited Platform Process Development

  • 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

High Throughput Cell Culture Process Development

  • Miniaturized bioreactors through the Ambr platform (Ambr® 15 and Ambr® 250)

  • 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

Seamless Scale-up in Single-use Bioreactors

  • Data from over 50+ molecules from bench scale to 200-2000L

  • Extensive mixing characterization studies at all scales

  • Accelerated development using in-house scalability data across cell line and process type

Biosimilars Process Development

  • Successful delivery of a large number of biosimilar programs

  • Well-versed in using multiple lots of innovator products to set ranges to drive clone selection and process optimization

  • Strength in analytical and biophysical characterization capabilities

  • Proven record of best-in-class process development

  • Control of product quality through the use of process parameters and supplements

Process Characterization & Scale-down Validation Studies

  • Ability to provide extensive reactor characterization studies across all scales starting from Ambr® 250 to the 2000L disposable bioreactor

  • Qualification of scale-down models for a wide range of bioreactor systems

Commercial Cell Culture Process Development

  • Advanced process control tools and strategies

  • Application of QbD principles to late-stage development

  • Use of PAT for improved process control

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