In biopharmaceutical and industrial protein production, the path to a stable and scalable manufacturing process does not begin at the bioreactor. By the time you optimize a process, the real foundation is already set: the production strain.
At VALIDOGEN, we embed manufacturability into the very first steps of strain development. This ensures that product quality and process performance are built in early - not corrected later.
Scale-up only works if the process does. And the process only works if the strain does.
Efficient process development is built on high-performance production strains, with commercial and regulatory expectations addressed from the very beginning.
Our UNLOCK PICHIA® technology platform provides a broad, flexible toolbox to enable the generation of industrial protein production strains reliably - without extending development timelines.
Why early focus on manufacturability matters
- Processes aligned with operational and regulatory expectations from the outset
- Predictable product yield and quality across scales
- Reduced risk of instability, impurity variability, and scale-up challenges
- Streamlined tech transfer
A proactive approach prevents late-stage surprises, and accelerates your progression towards pilot, industrial, or GMP-scale.
VALIDOGEN’s approach: Early Integration of Manufacturing Considerations
With our UNLOCK PICHIA® platform, VALIDOGEN integrates manufacturing requirements into strain construction from day one. This includes:
- Optimized yield and consistent product quality by exploiting our diverse molecular toolbox
- Simplified, safe, and scalable production using our methanol-free strains and processes
- Avoidance of antibiotic resistance marker genes with ARMs-free strains for safe use in Food & Feed
Translating strain potential into scalable, consistent processes
After strain generation, this molecular potential is transformed into robust, scalable, and reproducible protein production processes. Our bioprocess development framework leads to:
- Enhanced productivity through targeted process optimization
- Consistent performance across development stages, enabling smooth technology transfer and scale-up
- Transfer-ready documentation supporting transitions into pilot, industrial, or GMP production
- Foundational process understanding aligned with Quality by Design (QbD) principles to support defining CPPs and CQAs
Derisk your development pathway - integrate manufacturability into Pichia strain development and build robustness before you scale.
Contact us to learn more about VALIDOGEN’s Pichia strain development and early process development programs.
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