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Fast-track Antibody Development – Gene to DP in 11 Months

A powerful platform process, smart mitigation strategies, and state-of-the-art technologies – an elegant combination that can expedite your innovative therapeutics to the patients.

A powerful platform process developed by experienced scientists

At the core of Celonic’s 11-Month Gene to DP solution is a powerful platform process where multiple modules work seamlessly together to cut down risk and timelines of release.

  • Off-the-shelf, highly-precise IgG analytical methods ensure correct process understanding
  • Accelerated cell line development combines a cutting-edge FACS-based CLD process with ambr® screening and fast-track stability studies to deliver stable clones with reliable titers after 17 weeks
  • Attuned bioreactors ensure similar titers and product quality across different scales
  • Robust scale-up strategies are leveraged to generate clinical-grade GMP material within 3 months after final clone decision
  • A rigorous 5-step DSP platform process purifies IgGs consistently with limited optimization

Smart analytical data-based mitigation strategies

Implementation of well-thought-out risk-mitigation strategies, which starts very early in the development process, is key to Celonic’s 11-Month Gene to DP solution.

  • Protein production, ideally before CLD, helps feed early mitigation strategies
  • Method feasibility checks are done very early in the development timeline which gives us enough time to optimize analytical methods – when necessary
  • Early assessment of DSP conditions paired with rigorous analytical assessment takes DSP development off the critical path
  • Parallel-efficient USP runs and MCB production with top clones eliminate the usual two months-delay for stability confirmation
  • Aseptic filling in the DS facility enables delivery of DP only days after DS production

State-of-the-art technologies

Fast-track antibody development calls for best-in-class, high-throughput technologies to increase the effectiveness and productivity of development.

  • Celonic’s proprietary, royalty-free, CHO-K1 cell line – CHOvolution® – delivers titers up to 8 g/L (average 3 – 5 g/L)
  • High-throughput screening enabled by automated liquid-handling systems accelerates process and analytical method development
  • ambr® systems for quick identification of top clones and generation of reliable clone stability data
  • 12 x 3 L bioreactor system powered by Delta-V for efficient USP parameter screening
  • High-throughput 8 tip DSP robot helps quick screening for optimal resin and buffer combinations

A typical 11 Month Gene to DP timeline for an IgG1

With Celonic’s 11 months gene-to-vial approach, you can reach your value inflection point faster than ever.

An accelerated timeline from gene to initiation of phase 1 studies is an important goal for all biotech companies and patients awaiting these often life-saving medicines. Celonic has worked tirelessly to refine its platform processes, mitigation strategies, and technologies to enable rapid delivery of DP for clinical studies, converging on a typical timeline for initial clinical studies.

Leveraging the combination of approaches described here, Celonic has reduced the time to reliably go from gene to DP from the current standard 16–24 months to 11 months.