At Profacgen, we transform promising research into robust, scalable manufacturing processes. With over a decade of biopharmaceutical expertise, our state-of-the-art, multi-product facility delivers the expertise, equipment, and regulatory readiness to take your molecule from proof-of-concept to full cGMP manufacturing.
We specialize in both mammalian and microbial expression systems, ensuring flexibility to meet a wide range of therapeutic goals.
Request InformationWe provide an integrated, step-by-step approach to ensure your process is efficient, compliant, and ready for clinical and commercial production.
Our dedicated pilot production suites replicate full-scale manufacturing operations, enabling accurate simulation of process flow. This allows our team to refine parameters, identify bottlenecks, and validate methods before entering cGMP manufacturing.
We maintain similar equipment and control platforms between pilot and cGMP areas, ensuring rapid, low-risk technology transfer. This consistency eliminates unnecessary re-validation and speeds up time-to-market.
Our GE pilot purification systems and ultrafiltration units deliver high-purity, reproducible protein products. These systems are adaptable for both mammalian and microbial expression platforms, supporting diverse product pipelines.
We utilize homogenizers, centrifuges, and ultracentrifuges to enable efficient cell disruption and fractionation. These steps are optimized to preserve protein integrity while achieving high yields.
All analytical testing is performed with state-of-the-art, CFR-compliant instruments to ensure accuracy, traceability, and regulatory readiness for every batch.
Our scientists develop and validate bioassays tailored to your product, enabling functional characterization and potency measurement that align with clinical and regulatory expectations.
Process development at Profacgen is not a standalone service—it’s part of an end-to-end biomanufacturing ecosystem. We work closely with our:
Q: Can you scale my process from lab research to cGMP manufacturing?
Q: How do you ensure a smooth technology transfer?
Q: Do you work with both mammalian and microbial systems?
Q: How do you guarantee product purity and consistency?
Q: Can you develop assays specific to my product?
Q: What regulatory standards do you follow during process development?
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