Formulation and drug product development
Prepare your final product with our formulation and drug product development CDMO solutions.
What is formulation development?
Drug product formulation development converts bulk drug substances into their final forms, making them suitable for administration to patients. Excipients are often required in biologics formulation as these inactive ingredients can help stabilize even the most sensitive of drug substances.
What is drug product development?
Determining the compatibility of formulations with containers and closure systems during drug product development is essential. This ensures that the final drug product is safe, effective and stable over time and under different conditions. Quality control processes can also help to ensure consistent production and adherence to regulatory requirements.
Understanding our formulation and drug product development solutions
We can support you at all stages of your formulation and drug product development journey, including:
Pre-formulation
- pH and buffer screening to select the lead formulation buffer
- Osmolality, appearance, recon time, density and viscosity screening
Formulation
- Short-term stress stability studies
- Stabilizer screening: Antioxidants, surfactants, preservatives, cryoprotectants
Characterization
- Design of experiments (DoE) for formulation robustness
- Full factorial design or fraction factorial design
- Stress or accelerated stability studies to study parameter interactions
Why partner with Enzene for formulation and drug product development?
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 formulation and drug product development 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.