Recovery and Purification of (Bio)Pharmaceuticals Using (Nano)Materials

Abstract

Biopharmaceuticals main classes comprise recombinant proteins, antibodies, and nucleic-acid-derived products, while synthetic pharmaceuticals include a wide variety of organic compounds. The purification of (bio)pharmaceuticals, as part of downstream processing, is mainly carried out by chromatographic processes, which are responsible for the therapeutics high cost. Therefore, there is a crucial need on the development of novel and more efficient separation/purification processes or on the improvement of the current chromatographic-based ones, aiming at producing pharmaceuticals of high quality and at a lower cost. Amongst alternative techniques, it has been demonstrated that inorganic or organic (nano)particles, used in solid-phase extraction approaches, may be promising for the purification of pharmaceuticals. This chapter provides an overview on solid-liquid separation/purification processes used to obtain high purity and high quality pharmaceuticals. The main purification processes are described and summarized. The areas where there has been a sustainable progress, combined with improved therapeutic characteristics, are highlighted. Materials based on silica (nano)particles, carbon-based (nano)particles (carbon nanotubes, graphene and activated carbon) and magnetic (nano)particles are overviewed. Based on the reported results, nanotechnology may play a key role in future pharmaceutical developments and manufacturing, where the design of suitable functionalized (nano)particles is a crucial factor to enhance the selectivity and to obtain high purification and recovery yields of (bio)pharmaceuticals.

Ionic-liquid-based approaches to improve biopharmaceuticals downstream processing and formulation

“…Frontiers in Bioengineering and Biotechnology frontiersin.org proteins, such as fragment crystallizable (Fc)-fusion proteins and mAbs, can undergo several post-translational modifications (proteolysis, glycosylation, among others), making their accurate bioprocessing and, consequently, their characterization, difficult to achieve (Jenkins et al, 2008). Moreover, biopharmaceuticals are more unstable and sensitive to the conditions employed during the manufacturing process, storage, and handling, such as temperature and pH (Kesik-Brodacka, 2018;Tavares et al, 2019;Lin et al, 2021). Since biopharmaceuticals are highly prone to denaturation and degradation events, as well as to modifications in their amino acid and sugar patterns, the manufacturing conditions must be strictly controlled (Kesik-Brodacka, 2018;Lin et al, 2021).…”

“…Due to the massive growth and aging of global population and to the high incidence of autoimmune and chronic diseases, there is a huge demand for effective and safe drugs ( Kesik‐Brodacka, 2018 ; Tavares et al, 2019 ; O’Flaherty et al, 2020 ). The pharmaceutical industry is majorly governed by traditional low molecular weight and synthetic pharmaceuticals, which represent more than 90% of all drugs currently available ( Ferreira et al, 2016 ; Tavares et al, 2019 ). However, a relatively new class of therapeutic molecules, known as biopharmaceuticals, has been gaining increasing traction.…”

“…However, a relatively new class of therapeutic molecules, known as biopharmaceuticals, has been gaining increasing traction. Biopharmaceuticals, also known as biologics or biologic drugs, were first introduced in the 1980s and refer to all pharmaceutical products with therapeutic activity that are derived from biological sources ( Chen et al, 2018 ; Hong et al, 2018 ; US Food and Drug Admnistration, 2018 ; Tavares et al, 2019 ; O’Flaherty et al, 2020 ; Pereira et al, 2021 ). They represent an important fast-growing sector within the global pharmaceutical industry, constituting ca.…”

“…They represent an important fast-growing sector within the global pharmaceutical industry, constituting ca. one-third of all drugs currently under development ( Moorkens et al, 2017 ; Tavares et al, 2019 ; Pereira et al, 2021 ).…”

“…The manufacturing of biopharmaceuticals, also known as biomanufacturing, comprises two main stages—the upstream and downstream processing ( Jozala et al, 2016 ; Hong et al, 2018 ; Tavares et al, 2019 ). The upstream processing encompasses several events responsible to promote the growth of the host cell that will further express and produce the biomolecule of interest.…”