ProBioGen Introduces CMC Navigator™ to Help Biopharma Teams Select the Best CMC Path Forward

BERLIN, Germany, February 17, 2026 / Biotech Newswire / -- ProBioGen today introduces CMC Navigator™, a set of four clearly defined CMC service models designed to support biopharmaceutical companies across all key stages of protein Chemistry, Manufacturing and Controls (CMC) development. Each model addresses a distinct development or program need, helping teams navigate flexible CMC strategies and align scope, timelines, and execution with current priorities, ultimately adding value as programs move forward.

As biologics programs advance, CMC requirements evolve, biopharma teams need adaptable solutions that meet them wherever they are in their journey – whether the priority is accelerating first-in-human entry, preparing for seamless later-stage transfer, outsourcing specific CMC activities, or improving an underperforming cell line or manufacturing process. CMC Navigator addresses this variability by offering clear entry points, transparent scope, and a structured view of how ProBioGen supports different CMC needs across all development stages.

CMC Navigator translates ProBioGen’s expertise in protein CMC into a clear, structured, easy-to-navigate CMC collaboration framework. It enables teams to select the most appropriate CMC approach from the outset – without limiting scientific flexibility. At the heart of CMC Navigator are four defined CMC collaboration models, each aligned with a specific development need and set of priorities:
Sprint – a fast-track to first-in-human model focused on speed and maximum streamlining.
Scale – a bridge-to-commercial model designed for future scalability and seamless tech transfer.
Customize – a modular service model allowing clients to select only the CMC elements they are ready for.
Rise – a molecule revival model focused on re-engineering existing cell lines and manufacturing processes to improve performance and robustness.

"CMC Navigator is a practical collaboration framework shaped by what we see across client programs," said Dr. Gabriele Schneider, Chief Business Officer at ProBioGen. "In protein CMC, success often depends on making the right calls early—on scope, timing, and how the work will be executed. 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."

By moving beyond one-size-fits-all CMC approaches, CMC Navigator combines defined CMC service models with scientific adaptability – strengthening how ProBioGen supports its clients and providing even greater clarity as programs move from development decisions into clinical execution.

Learn more about ProBioGen’s CMC Navigator here.

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About ProBioGen
ProBioGen is a Berlin-based expert in the development and manufacturing of biopharmaceuticals, viral vectors, and vaccines, powered by proprietary technologies that enhance product quality and features. Operating for over 30 years, ProBioGen runs three manufacturing lines in Berlin, where 300 employees contribute to advancing next-generation therapies and global biotech innovation. The company’s growth strategy focuses on expanding its service value chain through organic growth and strategic opportunities, with a clear mission to enable tomorrow’s biopharmaceuticals. For more information about ProBioGen, follow us on LinkedIn.
 
Contacts
ProBioGe
Dr. Gabriele Schneider
Chief Business Officer
cdmo@probiogen.de
ProBioGen Press Contact
Sarah Wandrey
Senior Communications Manager
press@probiogen.de