Robust Processes From the Start
From bench to commercial scale, we develop bioprocesses built for reproducibility, regulatory confidence, and the long-term success of your program.
Processes Designed for Scale
Upstream Process Development
QbD-aligned fermentation optimization across fed-batch and batch modes, with scale-up bridging from development scale through to GMP production.
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Downstream Process Development
Full downstream scope covering product recovery, refolding, chromatography, TFF, and hollow-fiber filtration, all designed for commercial scale-up. Inclusion body refolding is supported by a dedicated high-capacity refold platform.
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Nucleic Acid Process Development
Dedicated pDNA purification laboratory with continuous flow cell lysis, CIM monolith chromatography, and TFF. Dedicated mRNA laboratory covering IVT, downstream purification, and microfluidic encapsulation development using the NanoAssemblr platform.
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Process Characterization
Critical process parameter identification and design space definition supporting consistent manufacturing performance. Scale-down model development supporting process validation and regulatory submissions.
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Integrated Analytical Support
Forced degradation studies, in-process testing, and phase-appropriate method development executed in parallel with process development throughout.
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Scale-Up Ready by Design
Discuss Your Program with Us
Connect with our experts and see how science-driven process development accelerates your path from bench to commercial manufacturing.