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Recent advances in (therapeutic protein) drug development
H A Daniel Lagassé1, Aikaterini Alexaki1, Vijaya L Simhadri1
1Hemostasis Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
F1000Research
|February 25, 2017
Summary
Emerging protein therapeutics offer novel treatments for various diseases. Advances in protein engineering enhance the safety and efficacy of these important medicines.
Area of Science:
- Biotechnology
- Pharmaceutical Sciences
- Drug Development
Background:
- Therapeutic proteins represent a critical class of medicines for unmet medical needs.
- Recombinant protein therapeutics target diverse indications such as cancers, autoimmune diseases, infectious agents, and genetic disorders.
Purpose of the Study:
- To review emerging trends and approaches in therapeutic protein drug development.
- To highlight recent advancements based on U.S. Food and Drug Administration-approved protein therapeutics.
Main Methods:
- Analysis of therapeutic proteins approved by the U.S. Food and Drug Administration between January 1, 2011, and August 31, 2016.
- Review of recent advances in protein-engineering technologies.
Main Results:
- Protein engineering allows for fine-tuning of protein characteristics, enhancing or maintaining safety and efficacy.
- A variety of novel protein therapeutics have been approved for clinical use.
Conclusions:
- Protein-based drug development is a rapidly advancing field with significant therapeutic potential.
- Continued innovation in protein engineering is key to developing next-generation protein therapeutics.
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