Quality is at the core of everything we build and operate. Our facilities incorporate key elements of GMP design—controlled environments, validated systems, and rigorous procedural discipline—supported by a comprehensive Quality Management System aligned with 21 CFR 211 and ICH Q7a principles. This structure gives clients the confidence that pilot-scale operations are executed with consistency, traceability, and regulatory awareness.
We support a wide spectrum of manufacturing needs, including fed-batch and continuous fermentation up to 1,500 L, along with customized purification strategies that accommodate proteins, enzymes, live microbial products, and specialty bioindustrial molecules. Each run is thoroughly documented, reviewed, and verified to meet global quality expectations.
From feasibility batches to pilot-scale manufacturing campaigns, we ensure that every lot reflects the integrity required for downstream development, partnership discussions, and early-stage regulatory planning. Our focus on quality enables clients to move forward with dependable material and a strong foundation for future commercialization.
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