Analytical & Formulation Development

Full Range of Analytical Development Capabilities

Bora Biologics fully supports method development & qualification, tech transfer & optimization, and method validation. Our broad analytical portfolio enables Bora to provide testing of the structural and physicochemical drug attributes, and to assess binding and functional activities with regards to the mode-of-action.

Read our special article to explore the importance of well-designed analytical testing throughout biopharmaceutical development, emphasizing strategies for success in meeting regulatory requirements and optimizing processes.

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Formulation Development for DS and DP

From tox to pre-clinical and clinical development, Bora Biologics provides full-range formulation services to fulfill clients’ needs. We specialize in developing liquid or lyo formulations in vial or prefilled syringe for different administration routes including intravenous, subcutaneous, intravitreal, and inhalation. Lyophilization cycle development and scale up can also be done in-house.

Our team carries out phase appropriate formulation development approach by DoE to ensure candidates move forward on designated timeline with an established drug substance and drug product stability program and justification for product shelf-life.

Bora utilizes a QbD approach to drug product process development and characterization to support your project from development toward commercial launch.

Robust biologics capabilities designed to accommodate biopharma’s unique needs

Our solutions for biologics include analytics and formulations development, cell-line and process development, and full cGMP manufacturing services.

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