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.
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
Paying for full-scale scope when you only need specific CMC elements.
Timelines
Generic setups can slow progress when speed to first-in-human is critical.
Goals
Pushing early-stage assets through heavy processes that misalign with your specific goals
Four Paths. One Clear Way Forward
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
Built for today, ready for tomorrow
- For biotechs 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
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
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.
Customer Quotes
Thanks to ProBioGen's continuous support and regularly provided valuable information — not only on technical challenges but also urgent issues associated with the project — our teams were able to bring a product from their facility to clinic as scheduled, within several months, here in Japan.
Director, CMC Development
Chiome Bioscience Inc.
Working with ProBioGen has been a highly rewarding experience. Their technical expertise, dedication to quality, and reliability, as well as industry-standard-exceeding results reaffirmed ProBioGen as the right partner for Marea. MAR002 holds promise as a first-in-class treatment for acromegaly... We appreciate ProBioGen's support throughout the process and look forward to continuing our collaboration as we advance to the next stages.
Chief Development Operations Officer
Marea Therapeutics