J.POD Solutions

providing partners with unmatched flexibility to quickly and cost-effectively produce high quality early phase clinical to commercial biologic drug substances

J.POD® biomanufacturing facility in Redmond, WA

  • The J.POD facility is an economical, small-footprint, deployable cGMP biomanufacturing plant
  • Configured to produce early development to commercial scale quantities of biologic products in support of multi-regional clinical programs and global commercial markets
  • Explore our full suite of CDMO services leveraging J.DESIGN

Our biomanufacturing approach

  • Process intensification with flexible, continuous processing performed in modular autonomous cleanrooms to reduce overall plant size
  • Single use systems and reconfigurable cleanroom pods for maximum flexibility
  • J.POD® accommodates perfusion, intensified fedbatch, semicontinuous, and end-to-end continuous biomanufacturing processes at a standard 500L scale to deliver a few kilograms for “first-in human” studies to metric tons of drug substance (commercial biomanufacturing) for large market commercial supply
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Productivity and quality benefits with an integrated, continuous, intensified approach

  • Just-Evotec Biologics has developed an integrated, continuous bioprocessing platform based on intensified perfusion cell culture, to provide a highly flexible and economic alternative to traditional scale-up or scale-out approaches for increasing mass output of drug substance
  • Productivity benefits: In our hybrid-continuous platform, by using intensified perfusion culture, we have achieved up to 10-fold higher productivity with a continuous harvest bioreactor format compared to traditional fed-batch cell culture
  • Product quality benefits: Cells maintain high viability in continuous perfusion culture as fresh media is continuously being added, and waste products are constantly being removed. Additionally, the mAb product is being harvested for purification from the bioreactor as it is expressed, which means it is in contact for less time with cells, cell culture components and impurities that could cause product degradation.
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Advancing process design for accessible monoclonal antibody (mAb) based therapeutics

  • A common challenge: How to rapidly develop and manufacture lead candidates and obtain approval for an IND or IMPD to progress into clinical trials
  • Choosing a cell culture process format is driven by the need for speed, low CoGs, and predictable performance
  • Just-Evotec Biologics uses intensified perfusion cell culture processes with significantly increased bioreactor productivity
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Figure 1

How early mAb optimization can improve developability and reduce costs

  • Most failures during the discovery and early clinical development of mAb-based therapies results from a lack of efficacy and/or safety issues
  • Intrinsic molecular properties can result in lead candidates that are difficult to manufacture or keep stable in formulation. This leads to process development and manufacturing challenges that have a significant impact on costs and timelines
  • Just-Evotec Biologics uses its Abacus™ software, an in-house suite of proprietary computational tools that enable prediction of the nest molecules and conditions for development
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