Sustainability by design for recombinant protein therapeutics

Area of Science:

• Pharmacology and Biotherapeutics
• Sustainable Manufacturing
• Drug Development

Background:

• Recombinant protein therapeutics are essential in modern medicine but face significant sustainability challenges.
• High attrition rates, resource-intensive production, and complex supply chains contribute to waste, emissions, and elevated costs.
• Increasing regulatory emphasis on sustainability and value-based healthcare intensifies these development hurdles.

Purpose of the Study:

• To propose a comprehensive strategy for enhancing the sustainability of recombinant protein therapeutic development.
• To highlight the importance of integrating compound design principles into sustainability efforts.
• To identify key criteria for maximizing the sustainability profile of biotherapeutics.

Main Methods:

• Analysis of current sustainability challenges in biotherapeutic development.
• Identification of critical compound design features (e.g., molecular format, half-life, stability).
• Evaluation of expression host efficiency and developability assessments.

Main Results:

• Optimizing processes alone is insufficient; integrating compound design is key to sustainability.
• Simpler molecular formats, extended half-lives, and enhanced stability reduce environmental impact and costs.
• Improved expression host efficiency and rigorous developability assessments further contribute to sustainability.

Conclusions:

• A holistic approach combining process optimization and intelligent compound design is vital for sustainable biotherapeutic development.
• Enhanced sustainability profiles will improve the competitiveness of future biotherapeutics.
• Sustainable practices align with global health goals, including the UN Sustainable Development Goals, by improving medicine accessibility.