Formulation of Biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs)

Dear Colleagues,

Biopharmaceuticals mainly comprise recombinant proteins that have brought innovative therapeutic solutions to different medical conditions, through biological and biosimilar medicines, which may contain monoclonal antibodies, cytokines, growth factors hormones, enzymes, vaccines or blood products. In addition, advanced therapy medicinal products (ATMPs), including genes, cells and tissues, offer alternative and effective clinical solutions to unmet medical needs.

The formulation of biopharmaceuticals and ATMPs is challenging due to the sensitivity of proteins, DNA and RNA, cells and tissues, which can also hinder their stability in the body environment. Furthermore, the high molecular size and hydrophilicity of most of these products prevent their passage through biological barriers. These limitations require that most of these medicines be for parenteral administration, which increases the cost of industrial manufacture and decreases patient adherence to therapy.

Several investigations have been conducted in the discovery of alternative non-invasive routes and/or delivery systems for biopharmaceuticals and ATPMs, and the results are promising, with medicines already approved for administration by non-parenteral routes. This special issue aims to update the state of the art of the latest developments in the formulation of biopharmaceuticals and ATPMs.

Dr. Ana Catarina Silva
Prof. Dr. José Manuel Sousa Lobo
Guest Editors

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