With a steadfast commitment to innovation and excellence, Just – Evotec Biologics is pioneering a new era in biologics manufacturing. Transitioning to our intensified continuous production before manufacturing at commercial scale can drive value creation in a late-stage manufacturing process.
For early-stage and first-in-human (FIH) clinical trials, the platform can operate a 15-day single bioreactor process to produce sufficient material. The same equipment can be scaled up for commercial biomanufacturing by running up to 6 bioreactors for 25-40 days, enabling flexible production from less than 10 kg to over 2,000 kg annually.
The platform reduces risks in several ways:
- Enables tunable product quality through upstream process controls
- Provides healthier cell cultures with better post-translational modifications
- Offers geographically diverse manufacturing sites in North America and Europe to mitigate supply chain risks
Before transitioning to commercial production, the company recommends a low-cost 3-month feasibility study that includes:
- Cell line evaluation
- High-throughput process development and COGM modeling
This low-cost study helps clients assess productivity impact and product quality effects while validating ROI assumptions.
For late-stage clinical trial and commercial manufacturing, the platform delivers significant advantages:
- 75% reduction in COGM compared to traditional fed-batch processes
- 10-fold higher productivity
- Flexible scaling capabilities through modular J.POD facilities.
The whitepaper also discusses typical timelines from cell line transfer to BLA-enabling studies for developing a continuous process for commercial manufacturing.
