- ProBioGen has introduced CMC Navigator™, a framework comprising four defined CMC service models for protein development.
- The models are designed to support biopharmaceutical companies across different stages of Chemistry, Manufacturing and Controls (CMC) development.
ProBioGen has introduced CMC Navigator™, a set of four defined CMC service models designed to support biopharmaceutical companies across key stages of protein Chemistry, Manufacturing and Controls (CMC) development. The framework is intended to help teams align scope, timelines, and execution with their program priorities as biologics advance.
According to the company, CMC Navigator addresses evolving CMC requirements by offering structured entry points and transparent scope across development stages. The framework is positioned to support companies accelerating first-in-human entry, preparing for later-stage transfer, outsourcing selected CMC activities, or improving existing cell lines and manufacturing processes.
At the center of CMC Navigator are four collaboration models: Sprint, a fast-track approach focused on speed and streamlined execution; Scale, designed to support future scalability and technology transfer; Customize, a modular option enabling clients to select specific CMC elements; and Rise, focused on re-engineering existing cell lines and manufacturing processes to enhance performance and robustness.
“CMC Navigator is a practical collaboration framework shaped by what we see across client programs. 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.”
Dr. Gabriele Schneider, Chief Business Officer at ProBioGen
The company stated that by combining defined service models with scientific flexibility, CMC Navigator strengthens how ProBioGen supports clients as programs progress from development decisions into clinical execution.
