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Stop Forcing Your Program into a Generic CDMO Box

With CMC Navigator™ you can choose one of four defined CMC service models with transparent scope and defined execution pathways.

Transparent Scope
Defined Execution
Aligned Expectations

Get Your CMC Strategy

Tell us about your molecule. We'll build the roadmap.

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30+
Years Experience
300+
Employees
450+
Cell Lines Developed
Global
Regulatory Reach

Different Programs Call for Different CMC Setups

Many CDMO offerings remain generic and inflexible, forcing programs into structures that do not reflect their actual situation or need.

Budget

Budget

Paying for full-scale scope when you only need specific CMC elements.

Timelines

Timelines

Generic setups can slow progress when speed to first-in-human is critical.

Goals

Goals

Pushing early-stage assets through heavy processes that misalign with your specific goals.

CMC Navigator™

Four Paths. One Clear Way Forward

Sprint Icon

Sprint

From DNA to clinic on a fast track

  • For biotechs under time pressure racing to first-in-human.
  • Fast-track, fixed-scope, fixed-price, based on proven platform processes.
  • IND-enabling TOX batch + GMP drug substance for Phase I.
  • Proven platform processes, fixed transfections, essential analytics (including stability).
Scale Icon

Scale

Built for today, ready for tomorrow

  • For biotechs needing Phase I/II GMP now while planning for what comes next.
  • More extensive development work, can start with multiple molecules in parallel.
  • Includes expanded process development, scalable methods, transfer-friendly process design, and GMP batches for Phase I and Phase II.
Customize Icon

Customize

Only what you are ready for

  • For biotechs not ready to engage in a full CMC program.
  • Most flexible CMC service model, can start with multiple molecules.
  • Delivered as clearly defined, stand-alone work packages.
  • Cell line development, process development, GMP drug substance, bioassay development, or analytical support only.
Rise Icon

Rise

Don't start over, start better

  • For biotechs and pharma companies with programs already in the clinic.
  • Molecule revival CMC model to strengthen existing assets and maximize their potential.
  • Replacement cell lines and/or manufacturing processes to improve titer, yield, stability, and scalability.

Interactive Selector

Find Your Strategy

Not sure which model fits? Use our guided tool to identify the optimal CMC path for your program.

Step 1 / 3

What is your primary constraint?

Select the critical driver for your program.

Step 2 / 3

Select Your Stage

Which profile best describes your organization?

Initializing...

Processing your constraints against our service matrix…

Recommended Strategy

Sprint

From DNA to clinic, on a fast track.

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CMC Navigator™

Why Partner With Us

We combine early alignment, transparency, and predictability at critical moments—supporting informed decisions and enabling a clearer transition from CMC strategy to clinical execution.

Lab

ProBioGen Introduces CMC Navigator™

to Help Biopharma Teams Select the Best CMC Path Forward.
450+

Cell Lines Developed

Blog

How Specialized CDMOs Lend an Edge to Your Drug Development Project