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?
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.