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Updated: Jun 13, 2025

Generic Protocol for Optimization of Heterologous Protein Production Using Automated Microbioreactor Technology
Published on: December 15, 2017
Sustainability by design for recombinant protein therapeutics
Renato Mastrangeli1, Maria Concetta Audino1, Steve Marquis Fernandes2
1Global CMC Development, CMC Science & Intelligence, Merck Serono S.p.A. (an affiliate of Merck KGaA, Darmstadt, Germany), Guidonia Montecelio, Rome, Italy.
None:
Recombinant protein therapeutics play a vital role in pharmacology, offering precise and effective treatments. However, their development faces sustainability challenges, including high attrition rates, resource-intensive processes, and complex supply chains, leading to waste, emissions, and high costs. Regulatory focus on sustainability and value-based healthcare further exacerbates these challenges. Current efforts primarily optimize processes, whereas a comprehensive strategy should integrate compound design (i.e. functional and physicochemical properties) to maximize sustainability. Key criteria include simpler molecular formats, extended half-lives, enhanced stability, rigorous developability assessments, and improved expression host efficiency. These reduce costs and emissions, and support the United Nations Sustainable Development Goals by expanding access to innovative medicines. A strong sustainability profile will be crucial for the competitiveness of biotherapeutics in the future.
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