Downstream process characterization
Evaluate and optimize your downstream processing performance with our characterization CDMO solutions.
What is downstream process characterization?
Downstream process characterization evaluates downstream purification processes using analytical methods to ensure consistent yield and purity of biologics.
With our downstream process characterization services, we can help you to:
- Identify bottlenecks in your process performance
- Adhere to regulatory requirements and quality standards
- Use process data to inform scale-up
Understanding our downstream process characterization
We can support your process characterization with studies including:
- Chromatography resin and membrane re-use
- Hold-time of in-process materials and buffers
- Clearance studies for process-related reagents and impurities
- Extractable and leachable studies including elemental and nitrosamine impurities
- Filter validation studies
- Virus clearance study design and execution
Why partner with Enzene for downstream process characterization?
We are a global CDMO and biosimilar developer dedicated to impacting the global healthcare landscape by bringing trusted and affordable medicines to market, quickly.
Committed to innovation, we have revolutionized biologics production with our patented and validated continuous bioprocess manufacturing platform, EnzeneX™, that enables us to significantly reduce the cost of producing complex biologics and monoclonal antibodies (mAbs).
Our fully-integrated services and productive pipeline of biosimilars, along with our downstream process characterization solutions, are designed to cater to your project’s every need.
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Join the CDMO revolution
Fueled by our continuous innovation and armed with EnzeneX™, our fully-integrated CDMO solutions and our biosimilars pipeline are designed to help bring your biologics innovations to life.