Why Early Process Development Determines the Success of Recombinant Protein Production
When advancing recombinant protein production towards scale-up for clinical or commercial manufacturing, many companies underestimate the strategic impact of pre-scale-up process development. Early focus on reproducibility and robustness is essential to enable:
- A reliable and predictable technology transfer and scale-up
- Avoidance of failed (clinical) batches which would have resulted in costly delays and missed production windows
- A strong data foundation to help define critical process parameters (CPPs)
Scale-up only works if the process does. Skipping development before scale-up leads to significantly more expensive rework later.
At VALIDOGEN, we help companies derisk scale-up at their CMO by building solid, transfer-ready processes based on our proven UNLOCK PICHIA® platform. With over 15 years of expertise, and a track record of our processes scaling up to 100,000 L, we ensure that early-stage process development delivers:
- Enhanced productivity through targeted process optimization - fine-tuning cultivation parameters to maximize yield.
- Robust and reproducible protein production processes that perform consistently across development stages and facilitate smooth scale-up to pilot and industrial levels.
- Transfer-ready documentation supporting seamless technology transfer, efficient transition into GMP or commercial production and regulatory filings.
- Foundational process understanding aligned with Quality by Design (QbD) principles, delivering data to inform critical process parameter (CPP) definition and critical quality attribute (CQA) control.
Building process robustness early in development is far more economical than troubleshooting during scale-up and implementation.
Contact us to learn more about VALIDOGEN’s early process development programs.