ProBioGen is launching CMC Navigator, comprised of four clearly defined service models aimed at chemistry, manufacturing, and controls (CMC) development.

Based in Berlin, ProBioGen intends to assist biopharmaceutical companies worldwide with all key stages of the protein CMC process.

How CMC Navigator Will Work

CMC Navigator is designed to accomplish this in the following ways, each expressing a distinct development need:

• Sprint: fast-tracking to first-in-human models focusing on speed and optimum streamlining
• Scale: a bridge to commercialization with considerations for future scalability and efficient tech transfer
• Customize: modular model allowing clients to select only the CMC elements applicable to them
• Rise: addressing molecule revival by re-engineering existing cell lines and manufacturing processes.

Gabriele Schneider, PhD, ProBioGen Chief Business Officer, said CMC Navigator’s development was based on prior evidence.

“CMC Navigator is a practical collaboration framework shaped by what we see across client programs,” Schneider said. “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.”

In this way, Schneider said, companies can choose the setup that fits their situation. After that, they will be able to move forward with aligned expectations and a clear plan.

Other ProBioGen News

In the past year, ProBioGen has kickstarted several partnerships. Chief among these, its selection to operate a process development and good manufacturing practice (GMP) production facility in Berlin.

Additionally, the company has an agreement with Zag Bio regarding thymus-targeted therapies. It is helping Spica Therapeutics advance a clinical development candidate in oncology. It has also combined with IAVI and Minapharm to expand vaccine and biologics production in Africa.

Lastly, ProBioGen agreed to conduct high-performance cell line development services for Polpharma’s biosimilar candidate.