Robust Mammalian Process Development for Biologics
At Olon, we help biotech and pharma innovators transform promising biologics into robust, scalable processes ready for GMP manufacturing. With 25 years of experience, we bring the scientific depth and flexibility needed to accelerate your program with confidence.
Process Development: The Critical Bridge to GMP Manufacturing
Process development is the stage where a molecule evolves from a research concept into a reproducible, scalable, and compliant process. Getting it right at this step ensures smoother clinical progress, reduced risk, and regulatory success.
At Olon , we integrate upstream and downstream expertise to design processes optimized for yield, quality, and regulatory alignment. Development begins in small-scale bioreactors (10 L and 40 L), progresses through pilot-scale runs (up to 250 L), and transitions seamlessly into GMP manufacturing at 1 000 L and 2 000 L.
Our teams work across a wide range of molecules — from monoclonal antibodies and Fc-fusion proteins to bispecifics and novel formats. By combining proven platform approaches with custom solutions, we de-risk development and give you confidence that your biologic can advance quickly and reliably into GMP production.
Comprehensive Upstream Development
Our upstream programs are designed to maximize cell growth, productivity, and product quality:
CHO and HEK293 expression systems
Fed-batch process optimization for robust, scalable yields
Media and feed strategies adapted to clone-specific needs
Scale-up studies from bench to 250 L pilot reactors
Real-time monitoring of critical parameters (pH, DO, metabolites)
Early product quality attribute assessment to guide clone and process selection
Advanced Downstream Development
Purification is where yield and quality are safeguarded. Our downstream team develops processes that balance efficiency, recovery, and regulatory compliance:
Platform Protein A purification for monoclonal antibodies
Custom purification schemes for Fc-fusions, bispecifics, and novel biologics
Unit operations including chromatography, filtration, and TFF
Development of robust viral clearance steps aligned with ICH, EMA, and FDA guidelines
Scale-down models to predict GMP performance and ensure reproducibility
By tailoring purification strategies to each molecule, we secure quality and stability without compromising yield.
Seamless Transition into GMP Manufacturing
At Olon France, process development is fully aligned with GMP manufacturing requirements from the start.
Development processes mirror scale-down versions of GMP protocols
Direct alignment with GMP documentation, QA, and QC expectations
Proven track record of smooth tech transfer into 1 000–2 000 L mammalian GMP facilities
Cross-functional collaboration between development, QA, QC, and regulatory teams
This ensures your biologic moves from development to GMP with minimal risk and maximum speed.
Frequently Asked Questions (FAQ)
What is mammalian process development?
It is the optimization of upstream (cell culture) and downstream (purification) processes to ensure biologics can be manufactured at high yield, quality, and regulatory compliance.
Which cell systems does Olon support?
We specialize in CHO and HEK293 cell lines, with expertise across monoclonal antibodies, Fc-fusions, bispecifics, and novel proteins.
What development scales are available?
We support process development from 10 L and 40 L small-scale bioreactors through 250 L pilot runs, ensuring scalability into GMP manufacturing at 1 000–2 000 L.
How does Olon ensure regulatory compliance during development?
We use scale-down GMP models, align documentation with ICH, EMA, and FDA guidelines, and integrate QA/QC oversight from the beginning.
Can Olon provide end-to-end support beyond process development?
Yes. Olon offers cell line development, mammalian GMP manufacturing, and aseptic fill & finish, ensuring continuity across the entire development cycle.
What makes Olon different from other CDMOs?
Our 25 years of experience, combined with integrated capabilities and a collaborative, transparent approach, make us a trusted partner for biotech and pharma companies worldwide.
We would love to hear about your development challenges and help you go one step further in your programme
Connect with our team and we will get back to your shortly.
