Early Clinical Supply
'What makes Just - Evotec Biologics stand out in the early clinical development space is our extensive knowledge base, commitment to clients, and quality of work. Our process development teams have years of experience across many different disciplines, and work together with our clients to ensure their project is delivered on time, with lowest risk and highest quality."
Rebecca Hernandez, Senior Director, Project Management
FIH Supply
At Just - Evotec Biologics we strive towards timelines of 9-13 month with our comprehensive offering for monoclonal Antibodies, Bispecifics, Fabs & Fusion Proteins.
Our deeply experienced team brings experience from both Pharma and CDMO worlds and has supported >100 biotherapeutics from preclinical to IND through late-stage clinical phases and launch. By combining unique biologics drug development expertise with our powerful continuous manufacturing platform, we ensure speed, success rate and quality at IND stage while already de-risking the path to launch and securing ultimate low COGS manufacturing process.
We apply a robust and proven platform approach for mAbs, Fc-fusion and multi-specific formats and can tailor program’s scope to best fit with the molecule specifications and meet our partners objectives. The platform uses high-throughput development and state-of-the-art analytical capabilities to ensure fast and reliable cell line and process development. Our intensified processes are directly scalable from 3L to 500/1000L which will represent both clinical and commercial bioreactor scales. With continuous manufacturing, there is no need or risk associated with scale-up.
Manufacturing for FIH Programs
- Scale down models are representative of 500L scale
- Thereby reduces need for engineering run(s)
- Scale from 3L to 500L cGMP run(s)
Why leverage continuous manufacturing for your FIH study?
- Gain access to highest productivity and quality level with minimum process development
- Secure timeline to IND; Just - Evotec Biologics' platform provides exceptional flexibility to meet clinical demand
- Avoid clinical re-supply
- Seamless transition to late-stage and commercial supply with minimal risk and variable demand
- Dedicated project manager for efficient communication and coordination
- Both CMC and COMMERCIAL strategies are DE-RISKED very early on
FIH Scope
- Lead sequence validation / further optimization towards increased "manufacturability" using Abacus® proprietary platform
- Cell Line Development (multiple options including proprietary and commercial hosts)
- Intensified process development (using proprietary media designed for lower COGS)
- Analytical development
- Formulation development
- Master cell banking
- Non-cGMP DS manufacturing
- Non cGMP / cGMP stability studies for DS & DP
- Regulatory support
- Coordination of DP activities (optional)
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