With over 5,000 critical process steps defining the success of a typical protein drug—magnitudes beyond small-molecule manufacturing—every stage from upstream to downstream directly impacts your total cost and final product quality. At Profacgen, we transform this complexity into your competitive advantage through our integrated development and characterization platform.
Our multifunctional expression platform delivers scalable solutions from milligrams to hundreds of grams. Equipped with a full spectrum of bioreactors—from traditional fermenters to innovative wave mixers—we support multiple expression systems tailored to your target protein's requirements. Beyond conventional methods, we pioneer enzymatic protein synthesis utilizing both traditional enzymes and high-throughput, computer-designed novel enzymes, providing powerful guarantees for protein drug design and industrial-scale manufacturing.
Our core expertise encompasses end-to-end process optimization: cell line development and strategic selection, upstream process development, and downstream purification process development. We troubleshoot and refine every stage using diverse, proven approaches. This service forms the backbone of our ability to accelerate your preclinical development timeline while ensuring robust, reproducible outcomes.
Leveraging advanced computational biology and our enzymatic synthesis capabilities, we engineer proteins with enhanced stability, activity, and manufacturability. This service directly supports the design and optimization phases critical for successful drug candidates.
Seamlessly bridge the gap from research to clinical readiness with our compliance-driven production suites:
We offer various cell line development options engineered for stable, reproducible industrial-scale production. Our strategies are designed to best meet your specific expectations and dramatically accelerate your preclinical drug development pathway. Our fermentation development ensures optimal grow shadow-style1th conditions, maximizing yield and quality.
Rigorous analytical testing is embedded throughout our workflow to define your product's critical quality attributes (CQAs). We deploy state-of-the-art methods to ensure comprehensive identity, purity, potency, and stability assessment.
Our downstream process development includes sophisticated profiling and clearance strategies for host cell proteins, DNA, leachables, and other process-related impurities, ensuring your product meets the highest safety and purity standards.
Contact us today to discover how Profacgen's Process Development & Characterization services can de-risk your journey and bring your protein therapeutic to market faster.
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