Building better biobetters: From fundamentals to industrial application

resumo

Biological drugs or biopharmaceuticals off patent open a large market for biosimilars and biobetters, follow-on biologics. Biobetters, in particular, are new drugs designed from existing ones with improved properties such as higher selectivity, stability, half-life and/or lower toxicity/immunogenicity. Glycosylation is one of the most used strategies to improve biological drugs, nonetheless bioconjugation is an additional alternative and refers to the covalent attachment of polymers to biological drugs. Extensive research on novel polymers is underway, nonetheless PEGylation is still the best alternative with the longest clinical track record. Innovative trends based on genetic engineering techniques such as fusion proteins and PASylation are also promising. In this review, all these alternatives were explored as well as current market trends, legislation and future perspectives.

palavras-chave

PLASMA HALF-LIFE; POLY(L-GLUTAMIC ACID); THERAPEUTIC PROTEINS; POLYETHYLENE-GLYCOL; BIOLOGICAL-ACTIVITY; FUSION PROTEINS; HYALURONIC-ACID; POLYMER; CONJUGATION; PEGYLATION

categoria

Pharmacology & Pharmacy

autores

Torres-Obreque, KM; Meneguetti, GP; Muso-Cachumba, JJ; Feitosa, VA; Santos, JHPM; Ventura, SPM; Rangel-Yagui, CO

nossos autores

agradecimentos

This work was funded by the Coordination of Superior Level Staff Improvement (CAPES/Brazil, finance code 001), the State of Sao Paulo Research Foundation (FAPESP/Brazil, process 2016/22065-5) and the National Council for Scientific and Technological Development (CNPq/Brazil, Fellowship #301832/20170 to C.O.R.Y.). This work was developed within the scope of the CICECO-Aveiro Institute of Materials project, UIDB/50011/2020 & UIDP/50011/2020, financed by national funds through the Portuguese Foundation for Science and Technology/MCTES. J. H.P.M. Santos acknowledges FAPESP for awarding the postdoctoral grant FAPESP #2018/25994-2.

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