Product characterization (R&D)
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?
We are a global Continuously Innovative Development and Manufacturing Organization (CIDMO), dedicated to changing the paradigm by which affordable biologic and biosimilar medicines are brought to market. Since Enzene’s inception, our innovative agility has enabled us to continually introduce transformative processes in biologics manufacturing that significantly increase product yields of complex biologics and monoclonal antibodies (mAbs) while reducing the manufacturing footprint and the cost of production.
Game-changing innovation is only the beginning, though. We are Enzene, and that means that our values of innovation, entrepreneurship, respect, candor, excellence, and integrity underscore everything we do from project management and communications to teamwork and ideation. To us, true partnership is about driving biotech innovation while doing so in a way that develops long-lasting trusted partnerships.
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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.