Antarctic ecosystems host psychrophilic and psychrotolerant fungi whose set of adaptations represents a biotechnologically valuable and underexploited genetic resource. This review synthesizes the current literature on the bioactive secondary metabolites and cold-active enzymes produced by Antarctic fungi, together with their biomedical, cosmetic, and industrial applications, and examines the regulatory and ethical framework governing their exploitation under the Antarctic Treaty System. Antioxidant, antimicrobial, anti-inflammatory, and photoprotective compounds—together with cold-active lipases, proteases, and amylases—were identified as the main classes of biotechnologically relevant molecules, with the Cadophora genus and the lipase B of Moesziomyces antarcticus (Candida antarctica) (CALB) highlighted as paradigmatic cases. Evidence considered shows that, despite promising bioactivities and at least one globally commercialized product (CALB/Novozym®), most findings remain confined to the academic level, revealing an early-stage translational field. The CALB case further exposes an unresolved regulatory gap: minimal, non-destructive sampling can generate substantial commercial value without any derived benefit for either the country of the researchers involved in the isolation, Antarctica, or the international community. These findings underscore the need for a specific legal instrument within the Antarctic Treaty System establishing rational bioprospection guidelines and mechanisms for equitable benefit-sharing.
ENZ-124, the first approved cetuximab biosimilar by Indian health authorities, was developed using the Chinese hamster ovary cell line, whereas the SP2/0 cell line was used for developing cetuximab originator (Erbitux®). Hence, this assessment aimed to evaluate the physiochemical, structural, and biological characterization of four batches each of Cetuxa®, Lupitux® and cetuximab originator. Analytical methods like peptide mapping (liquid chromatography–tandem mass spectrometry [LC-MS/MS]), glycan mapping (liquid chromatography–fluorescence detection), isoform analysis (hydrophobic interaction chromatography [HIC]-high-performance liquid chromatography), charge variant analysis (capillary electrophoresis coupled with mass spectrometry), FcγRIIIa binding assays, cell-based antibody-dependent cell-mediated cytotoxicity (ADCC) measurement, and host cell protein analysis (LC-MS/MS) were utilized for analysis. Variations in physicochemical and biological attributes were observed between cetuximab originator and its biosimilars. HIC analysis revealed C-terminal heterogeneity and increased hydrophobicity in biosimilars, that with the different N-glycan profile affected charge distribution. Charge variant analysis indicated a more acidic profile for the biosimilars. The biosimilars showed higher oxidation levels and misincorporation. The biosimilars also showed an enhanced FcγRIIIa binding affinity and in vitro ADCC activation compared with cetuximab originator. The study outcomes highlight the ability to differentiate cetuximab originator from its biosimilars Cetuxa® and Lupitux® based on the observed physicochemical and biological differences.
Curcuminoids (Cmn) are polyphenolic compounds from Curcuma longa that exhibit significant pharmacological activities but suffer from poor bioavailability due to low solubility and rapid metabolism. We have developed a novel formulation of Cmn entrapped within citrus fibers with the intent to improve its bioavailability. The physiological properties of citrus fibers improve aqueous dispersion and apparent solubilization of Cmn while protecting it from physiological degradation. Single-dose oral pharmacokinetics in Wistar rats revealed that citrus fiber-entrapped Cmn (CurcXR) exhibited a 57.52-fold increase in bioavailability compared to 95% standard Cmn. The maximum plasma concentration (Cmax) of 0.95 μg/mL at 4 h, and an area under the curve (AUC0−t) of 8.84 μg/mL·h was observed for CurcXR. These findings highlight that citrus fiber-based formulations are a simple, safe, and effective strategy to enhance the bioavailability of Cmn in nutraceuticals.
Bringing a new drug to market is a complex, costly, and lengthy process, averaging $2.6 billion and about ten years of research and development. It involves multiple stages, from target discovery to post-approval monitoring, and relies heavily on innovation driven by collaboration among pharmaceutical sciences, biology, biochemistry, engineering, and artificial intelligence. Drug discovery can be divided into four main stages: target selection and validation; compound screening and optimization; preclinical studies; and clinical trials. First, researchers identify and validate a biological target associated with a disease using genomic, proteomic, and bioinformatic approaches. Next, potential compounds (“hits”) are identified through methods such as high-throughput and virtual screening, followed by iterative chemical optimization and functional testing. Promising candidates undergo preclinical in vivo studies to assess pharmacokinetics, pharmacodynamics, and toxicity. Clinical development proceeds in three phases: Phase I evaluates safety in healthy volunteers; Phase II assesses efficacy in patients; and Phase III confirms efficacy and safety in larger populations. After successful trials, regulatory agencies review the data for approval. While small molecules have long dominated due to their stability and oral bioavailability, biologics—such as monoclonal antibodies and mRNA-based therapies—have grown rapidly, highlighted by COVID-19 vaccine development and increasing FDA approvals.
Background: Conventional drug delivery systems often lead to fluctuating plasma concentrations (“Peak and Trough” phenomenon), causing toxicity or inefficacy. Microfluidics has emerged as a revolutionary tool to overcome, among other applications, the limitations of conventional bulk encapsulation methods, such as polydispersity and poor reproducibility. Methods: A systematic review of the literature published between 2020 and 2025 was conducted to evaluate the application of microfluidics in the synthesis of advanced nanomedicines. The review focused on Lipid Nanoparticles (LNPs), Polymeric Nanoparticles (PNPs), and Hydrogel Microspheres. Results: Microfluidics enables the production of monodisperse particles with precise control over geometry and drug loading stoichiometry. Key therapeutic applications include oncology (passive and active targeting), gene therapy (mRNA vaccines), and regenerative medicine (diabetic wound healing). Conclusions: While microfluidics offers superior quality control compared to bulk methods, industrial scalability remains the primary challenge, currently addressed through parallelization and continuous flow strategies.
