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Formulation of Recombinant Therapeutic Proteins: Technological Innovation, Regulations, and Evolution Towards Buffer-Free Formulations
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DOI：10.3390/pharmaceutics17091183.png)
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Abstract
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Background/Objectives: Formulating recombinant therapeutic proteins is essential to ensure their safety, efficacy, and stability. A growing trend in biopharmaceutical development is the move toward buffer-free formulations, which aim to reduce immunogenicity, improve tolerability, and simplify production. This review explores technological advances, regulatory perspectives, and safety considerations related to this shift. Methods: A systematic documentary review was conducted using the PSALSAR framework. Scientific publications, patents, and regulatory documents (2020–2025) were retrieved from PubMed, Scopus, Web of Science, and regulatory databases (FDA, EMA). Inclusion criteria focused on recombinant proteins, buffer-free formulations, and regulatory alignment. Results: The findings reveal an increasing adoption of self-buffering strategies in high-concentration subcutaneous biologics. Technologies such as Fc-fusion, PASylation, and XTENylation enhance stability without conventional buffers. Regulatory bodies are progressively accepting minimalist formulations, provided safety and biosimilarity are demonstrated. However, intellectual property barriers limit formulation transparency. A synthesis of recent FDA and EMA approvals illustrates this formulation evolution. Conclusions: Buffer-free formulations offer a promising alternative for therapeutic protein development by improving patient experience and reducing formulation complexity. They align with biosimilar goals and regulatory trends, although long-term transparency and safety assessments remain critical for widespread adoption.
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