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University of Strathclyde and Target Healthcare Limited, KTP 21_22 R4

This project aims to develop a comprehensive understanding of formulation, characterization, and analysis techniques. It seeks to build platform capability and establish a robust framework for assessing the shelf-life and stability of various aseptically prepared Monoclonal Antibodies for patient use.

Feedback Overview:

The idea is highly innovative and addresses a critical need in the pharmaceutical and biotechnology industries. To successfully reach product-market fit, it is essential to demonstrate the practical applications and benefits of the developed framework. Collaborating with industry partners and continuously iterating based on feedback will increase the business value of this venture.

Market Competitors:

Market Competitor

Market Competitor

Market Competitor

Market Competitor

Market Competitor

Market Competitor

Chief Scientific Officer

Expertise in drug development, formulation, and regulatory compliance.

How can we ensure the developed framework meets regulatory standards?

By aligning the framework with existing regulatory guidelines and involving regulatory experts throughout the development process.

What are the key challenges in developing a robust framework for shelf-life assessment?

Key challenges include ensuring accuracy in predictive models, accommodating variability in antibody formulations, and validating the framework with real-world data.

How can we demonstrate the practical benefits of this framework to industry stakeholders?

By conducting case studies and pilot projects that showcase the framework's effectiveness in improving shelf-life predictions and stability assessments.

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