Product characterization
Enhance your drug development and manufacturing with our comprehensive drug product characterization solutions.
Why is product characterization important?
Product characterization is a critical step in drug development as it helps to ensure:
- Safety: By understanding the drug’s solubility, stability and metabolism, potential side effects can be assessed
- Efficacy: By understanding the drug’s pharmacokinetics and pharmacodynamics, dose and delivery schedule can be optimized to maximize its therapeutic effects
- Quality: By establishing and monitoring critical quality attributes (CQAs), manufacturers can ensure that the drug meets all regulatory requirements and is safe and effective when administered to patients
- Regulatory compliance: Regulatory agencies such as the FDA and EMA require manufacturers to provide comprehensive data on the physicochemical and biological properties of their drug candidates to assess their safety and efficacy
Understanding our product characterization
Our team of experts and state-of-the-art analytic facilities provide you with extensive product characterization, from early-stage development to commercial manufacturing.
Our analytical instruments include:
- HPLC & UPLC
- Solo VPE
- DSC
- Maurice
- Plate reader
- Electrophoresis unit
- RT-PCR
- Xevo G2-XS Mass spectrometer
- PA800 Plus
- Jasco CD Spectrophotometer
Why partner with Enzene for product 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 product 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.