Accelerating and Streamlining Microbial Process Development with a Novel Technology
Information
The complexity and diversity of microbial-expressed biologics remains a challenge that can lead to costly and time-consuming process development work, particularly during downstream development. While traditional affinity chromatography is the norm for standard antibody-based therapies, there are limited approaches for more complex antibodies, antibody fragments, and non-antibody-based therapies.
Leveraging deep process knowledge across hundreds of microbial-expressed proteins, FUJIFILM Biotechnologies has developed a novel technology to enable rapid and efficient progression from gene to cGMP manufacturing across various microbially expressed modalities.
This technology enables a more standardized affinity-based chromatography approach without the negative effects that some other technologies pose. This approach integrates seamlessly with our established Paveway™ PLUS microbial expression system to deliver high-quality early-stage material suitable for product-quality assessment and provides a direct, scalable pathway toward cGMP-ready processes.
The presentation describes the development of the technology, highlights its workflow advantages, and demonstrates its impact on reducing timelines through reducing manufacturing complexity —ultimately enabling our partners to advance smoothly toward toxicology and clinical-grade material production.
