ProBioGen debuts CMC Navigator to guide biopharma teams through protein development pathways
ProBioGen, the Berlin-based contract development and manufacturing organisation (CDMO), has introduced CMC Navigator™, a structured framework comprising four defined service models aimed at supporting biopharmaceutical companies through the key stages of protein Chemistry, Manufacturing and Controls (CMC) development.
Addressing variability across development stages
As biologics programmes progress, their CMC requirements shift considerably. Teams may need to accelerate first-in-human entry, prepare for later-stage technology transfer, outsource discrete CMC activities, or rescue an underperforming cell line. CMC Navigator is designed to address this variability by providing clear entry points, transparent scope definitions, and a structured view of available support across all development stages — without constraining scientific flexibility.
Four defined collaboration models
At the core of CMC Navigator are four distinct models, each aligned to a specific programme need:
• Sprint is a fast-track model focused on speed and streamlining, aimed at teams prioritising first-in-human entry.
• Scale is a bridge-to-commercial model built for future scalability and seamless technology transfer.
• Customize operates as a modular service model, enabling clients to select only those CMC elements relevant to their current stage of readiness.
• Rise is a molecule revival model, focused on re-engineering existing cell lines and manufacturing processes to improve performance and robustness.
Structured clarity without limiting scientific flexibility
The framework translates ProBioGen’s protein CMC expertise into a collaboration structure that allows teams to identify the most appropriate approach from the outset. According to Dr Gabriele Schneider, Chief Business Officer at ProBioGen, early decision-making is critical to programme success.
“In protein CMC, success often depends on making the right calls early – on scope, timing, and how the work will be executed,” said Dr Schneider. “CMC Navigator helps biopharma teams navigate those decisions by selecting one of the four paths, so they can choose the setup that fits their situation and move forward with aligned expectations and a clear plan from the start.”
ProBioGen has operated for over 30 years and employs approximately 300 staff across three manufacturing lines in Berlin. The company’s portfolio encompasses biopharmaceutical development and manufacturing, viral vectors, and vaccines, supported by proprietary technologies.
For more information, visit: www.probiogen.de
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