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CELL CULTURE, IND SUBMISSIONS, & COMMERCIAL LAUNCHES

Cell Culture Process Analytical Development

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.

cell culture KBI ambr 250-1472232266

 

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 about 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.

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

Industry Leading

scientific methodologies in high throughput process development

40+

annual programs ranging from FIH process development to late-stage process development, characterization & validation

15+

IND submissions supported annually

Presentation | Scalability of a Single-use Bioreactor Platform for Biopharmaceutical Manufacturing

Presentation | Scale-up & Tech Transfer from Non-Disposable to Fully Disposable Systems

White Paper | Integrated utilization of high-throughput bioreactors & high-throughput analytics for rapid & robust cell culture process development

Presentation | Debottlenecking Manufacturing Capacity: Initiating cell culture manufacturing campaigns using seed train cryopreserved in a disposable bag

Presentation | Optimization of Glycosylation & Charge Distribution Through Culture Parameters & Supplements

Publication | Up to Speed: European Biopharmaceutical Review, July 2016

 

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

  • Learn more: Case Study | Improving Titer

High Throughput Cell Culture Process Development

Process Characterization & Scale-down Validation Studies

  • Ability to provide extensive reactor characterization studies across all scales starting from ambr250 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