Eden Biologics fully supports method development & qualification, tech transfer & optimization, and method validation. The broad analytical portfolio enables Eden to provide testing of the structural and physicochemical drug attributes, and also to assess binding and functional activities with regards to the mode-of-action.
Analytical & Formulation Development
- Develop liquid or lyo formulations in vial or prefilled syringe for different administration routes including intravenous, subcutaneous, intravitreal, and inhalation
- Carry out phase appropriate formulation development approach by DoE to ensure the drug candidate can move forward on clinical phase on designated timeline
- Establish a drug substance and drug product stability program and justification for product shelf-life
- Drug product process development and characterization by QbD approaches starting from the development stage & each clinical phase, and towards commercial launch
- Lyophilization cycle development and scale up can also be done in-house
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