Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Reinventing Therapeutic Proteins: Optimizing Investments and Meeting Humanitarian Needs

Version 1 : Received: 24 March 2023 / Approved: 27 March 2023 / Online: 27 March 2023 (14:02:03 CEST)

A peer-reviewed article of this Preprint also exists.

Niazi, S.K.; Mariam, Z. Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies. Biologics 2023, 3, 72-94. Niazi, S.K.; Mariam, Z. Reinventing Therapeutic Proteins: Mining a Treasure of New Therapies. Biologics 2023, 3, 72-94.

Abstract

Reinventing approved therapeutic proteins for a new dose, a new formulation, a new route of administration, an improved safety profile, a new indication, or a new conjugate with a drug or a radioactive source is a creative approach to benefit from the billions spent on developing new therapeutic proteins. These new opportunities were created only recently with the arrival of AI/ML tools and high throughput screening technologies. Furthermore, the complex nature of proteins offers mining opportunities that are not possible with chemical drugs; bringing in newer therapies without spending billions makes this path highly lucrative financially while serving the dire needs of humanity. This paper analyses several practical reinventing approaches and suggests regulatory strategies to reduce development costs significantly. This should enable the entry of hundreds of new therapies at affordable costs.

Keywords

Therapeutic proteins; Recombinant proteins; Repurposing; Reinventing, Drug-antibody combinations, AI/ML, Efficacy improvement, Immunogenicity; Artificial Intelligence; mRNA; High throughput analysis

Subject

Medicine and Pharmacology, Pharmacology and Toxicology

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