At Profacgen, our state-of-the-art, certified facility is designed for multi-product operations, enabling seamless transitions from proof-of-concept to cGMP manufacturing for clinical trials, market launch, and commercial supply.
From the very first experiment to final delivery, our advanced infrastructure and professional expertise ensure a smooth, reliable pipeline for novel biopharmaceutical development.
Request InformationWe maintain strict adherence to FDA cGMP guidelines, ensuring product safety, quality, and regulatory readiness. Our facility is purpose-built to support every stage of biopharmaceutical production.
Our production areas include qualified Class 10,000 and Class 100,000 cleanrooms, equipped with Class 100 biohoods to maintain strict particulate control. These environments are regularly monitored and validated to ensure compliance with global cleanroom standards, enabling consistent product quality.
We operate separate cleanroom suites for upstream ( fermentation, cell culture ) and downstream ( purification, formulation) processes. This segregation minimizes the risk of cross-contamination and maintains process integrity from start to finish.
Our fully equipped quality control labs operate independently from manufacturing to provide unbiased product verification. Equipped with advanced analytical instrumentation, they ensure each batch meets defined specifications before release.
We offer secure Master and Working Cell Bank creation, storage, and management in GMP-compliant facilities. Redundant storage systems and strict monitoring guarantee long-term viability and traceability of your production cell lines.
Our facility supports the expression, production, and purification of proteins from both mammalian and microbial systems. This dual capability provides flexibility for a wide range of biologics, from research-grade proteins to commercial supply.
Whether you require small-scale clinical trial batches or full commercial supply, our facility is equipped to deliver with efficiency and reliability—ensuring your product moves forward without delays.
Q: What cGMP standards does your facility comply with?
Q: What cleanroom classifications do you have?
Q: Can you handle both mammalian and microbial protein production?
Q: How do you ensure product quality and consistency?
Q: Do you offer cell banking services?
Q: Can you support my product from early-stage development through to commercial supply?
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