Journal of Pharmaceutical and BioTech Industry

Background: Avidin (AV) represents the third most important protein of major commercial interest derived from egg white, alongside ovotransferrin and lysozyme. It constitutes only 0.05% of the total protein content. Despite the widespread natural availability of AV, its purification remains a significant challenge due to its low abundance within a highly concentrated and complex protein matrix. Methods: Developing efficient downstream processing for AV has the potential to significantly enhance profitability within the egg protein industry. This work presents a novel integrated process for AV recovery. It comprises ovomucin removal, AV preconcentration, and final purification using pseudo-affinity chromatography. The latter utilizes a novel resin with 4′-hydroxyazobenzene-2-carboxylic acid (HABA) as the ligand. The HABA–agarose matrix was characterized by an adsorption isotherm and breakthrough curves, indicating an AV adsorption performance higher than that of other pseudo-affinity matrices. Results and Conclusions: The HABA pseudo-affinity chromatographic process was a crucial step to purify AV more than 300-fold with high yield (86%). Despite the low AV recovery, the proposed integrated process aligns with the biorefinery concept, which maximizes the economic value of raw materials by utilizing all components. Full article

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. Full article

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 (C_max) of 0.95 μg/mL at 4 h, and an area under the curve (AUC_0−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. Full article

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. Full article

Background: Histoplasmosis is a major opportunistic fungal infection in immunocompromised individuals, particularly people living with HIV in Latin America. Early diagnosis is essential to reduce morbidity and mortality, but commercial urinary Histoplasma antigen assays are not consistently accessible in many endemic settings. Methods: We developed a locally produced enzyme-linked immunosorbent assay (ELISA) to detect urinary Histoplasma antigen in urine and performed a preliminary clinical evaluation. The assay is based on a sandwich ELISA format using rabbit polyclonal antibodies raised against whole-killed yeast cells of Histoplasma capsulatum. Receiver operating characteristic (ROC) analysis was performed with urine samples from patients with progressive disseminated histoplasmosis (PDH) (n = 37) and healthy controls (n = 20). An exploratory disease-control panel (n = 11) was also tested to assess cross-reactivity. Preliminary analytical characterization included blank-based estimation of the limit of detection (LOD) and limit of quantification (LOQ). Results: Using a Youden-derived cutoff of OD₄₉₂ = 0.243, the in-house ELISA showed a sensitivity of 73.0% (27/37; 95% CI: 55.9–86.2%) and a specificity of 100.0% (20/20; 95% CI: 83.2–100.0%) in the main ROC dataset, with an area under the curve of 0.856. In the exploratory disease-control panel, 2 of 11 specimens were reactive (one paracoccidioidomycosis and one cryptococcosis sample). Preliminary LOD and LOQ estimates were 4.46 ng/mL and 8.15 ng/mL, respectively. Conclusions: This locally developed ELISA represents a feasible and cost-effective alternative for urinary antigen detection of Histoplasma, with potential to improve access to early diagnosis in resource-limited settings. However, its current performance should be considered preliminary. Additional optimization and broader validation, including direct comparison with commercial assays, inter-assay precision, reagent stability, and larger multicenter control panels, are required before routine clinical implementation. Full article

Personalized transdermal drug delivery systems (TDDS) represent a transformative approach in precision medicine by enabling patient-specific, non-invasive, and controlled therapeutic administration. Conventional transdermal patches are limited by fixed dosing, passive diffusion, and interindividual variability in skin permeability and metabolism, often leading to suboptimal therapeutic outcomes. Recent advances in materials science, nanotechnology, microneedle engineering, and digital health have enabled the development of next-generation personalized TDDS capable of programmable, adaptive, and feedback-controlled drug release. Smart wearable patches integrating biosensors, microfluidics, microneedles, and wireless connectivity allow real-time monitoring of physiological and biochemical parameters, enabling closed-loop drug delivery tailored to individual metabolic profiles. Nanocarriers such as lipid nanoparticles, polymeric nanoparticles, and stimuli-responsive hydrogels further enhance drug stability, penetration, and controlled release, while 3D-printing technologies facilitate patient-specific customization of patch geometry, drug loading, and release kinetics. Artificial intelligence (AI) and machine learning tools are increasingly being employed to predict drug permeation behavior, optimize enhancer combinations, and personalize dosing regimens based on pharmacogenomic and pharmacokinetic data. Despite these advances, regulatory complexity, manufacturing standardization, long-term biocompatibility, and cybersecurity considerations remain critical challenges for clinical translation. This review highlights recent innovations in personalized TDDS, discusses their clinical potential, and examines regulatory and technological barriers. Collectively, these emerging smart transdermal platforms offer a promising pathway toward adaptive, patient-centered therapeutics that can significantly improve treatment efficacy, safety, and compliance. Future research should focus on integrating multimodal biosensing, advanced biomaterials, scalable manufacturing strategies, and robust regulatory frameworks to enable clinically validated, fully autonomous transdermal systems that can dynamically adapt to real-time patient needs in diverse therapeutic settings. Full article

Background: Accidents caused by the Loxosceles laeta spider constitute a health problem in South America. Envenomation can lead to severe systemic manifestations, eventually compromising the patient’s life. Most regional health authorities consider antivenom administration the basis of effective treatment in the most serious cases. The availability of spider venom is the primary bottleneck for antivenom production. Herein, we present a novel biotechnological approach, based on the expression of recombinant versions of the most relevant toxin in loxoscelism, sphingomyelinase D (SphD), in insect larvae (Spodoptera frugiperda). Methods: We produced two versions of SphD: one conserving its biological activities (wtSphD) and a second alternative that was designed to be genetically detoxified (dSphD). Two horses were subjected to three consecutive hyperimmunization cycles with dSphD. The horses’ plasma was extracted at the end of each cycle and used to produce Active Pharmaceutical Ingredients (APIs) of antivenoms at a pilot scale. Results: Dermonecrotic activity of wtSphD was completely neutralized with the sera obtained from one horse and partially with that of the other. In contrast, the APIs derived in both cases completely neutralized wtSphD dermonecrotic activity. Direct hemolysis of human red blood cells by wtSphD was also neutralized by sera and APIs. Conclusions: These results show venom replacement or complementation potential by recombinant dSphD produced in this novel platform. Full article

Viral vectors such as adenovirus (Ad) and lentivirus (LV) are central to gene therapy owing to their transduction efficiency and broad applicability; however, their clinical translation is often limited by immunogenicity, rapid clearance, and reduced bioavailability. Non-enveloped Ad vectors are highly susceptible to neutralization by pre-existing antibodies, while enveloped LVs remain vulnerable to immune surveillance and off-target clearance. In this study, a biomimetic encapsulation strategy using erythrocyte-derived membranes (EDMs) is reported to enhance viral immune resilience and functional gene delivery. Ad-GFP and LV-mCherry were successfully encapsulated within EDM using an extrusion-based assembly approach, resulting in uniform membrane-coated particles with physicochemical properties characteristic of erythrocyte membranes. EDM encapsulation significantly enhanced in vitro transduction efficiency of both viral platforms across multiple cancer cell lines without compromising viral activity. Notably, EDM-Ad-GFP demonstrated robust protection against neutralizing antibodies, achieving significantly higher transduction of HEK293 cells in the presence of diluted human serum compared to unencapsulated Ad. These findings indicate that EDM encapsulation can effectively shield viral vectors from immune recognition while improving cellular uptake and transduction performance. Collectively, this work establishes EDM encapsulation as a versatile and scalable platform to enhance the efficacy, durability, and translational potential of viral gene delivery systems. Full article

Insulin injection remains the best therapy for diabetes mellitus, but subcutaneous injection continues to pose challenges, including patient discomfort, poor compliance and fluctuating plasma glucose profiles. Recently, transdermal insulin delivery has emerged as a non-invasive strategy that bypasses gastrointestinal degradation and first-pass hepatic metabolism, thereby increasing insulin bioavailability and enhancing patient acceptance. Recent developments in nanomedicine have facilitated the development of transdermal patches with enhanced drug encapsulation, uptake and controlled release. Nanostructured lipid carriers, polymeric nanocomposites, liposomes and SLNs have demonstrated a five-fold enhancement of transdermal flux and an extended insulin effect in preclinical models. The addition of ionic liquids and polymeric nanogels leads to an additional increase in insulin aqueous solubility and permeation, resulting from the temporary regulation of stratum corneum lipid organization. Bright and stimuli-responsive patches with glucose oxidase or phenylboronic acid functional groups enable regulated insulin delivery in response to changes in blood glucose, demonstrating near-normoglycemia for up to 48 h in animal testing. Nanocomposite systems assisted by microneedles have also been advanced to the early clinical phase, offering enhanced reproducibility of their pharmacokinetics and a low risk of dermal irritation. Despite these encouraging results, several translational challenges remain, such as biocompatibility, repeatability in the production of nanocarriers, long-term stability of formulations and regulatory standardization. This review examines the physicochemical design principles, materials innovations and permeation mechanism of nanomedicine-engineered insulin patches, the current state of preclinical and clinical advancements, challenges in production and future perspectives in viable patient-focused transdermal insulin delivery. Full article

Background: Fetuin (Ft) is the most abundant protein in fetal bovine serum (FBS) and is considered one of its essential components. This acidic glycoprotein plays a key role in cell adhesion and proliferation and is vital for maintaining in vitro cultures of animal and human cells, tissues, and organs. FBS is a natural source for Ft purification. However, the high demand for FBS as a standard reagent in cell culture severely limits its availability for use as a raw material for protein purification. Furthermore, the industrial production of FBS results in a significant amount of contaminated FBS. This contaminated fraction can thus be utilized for Ft recovery. Methods: In this work, we present a novel method for Ft recovery from FBS using a single chromatographic step based on anion exchange chromatography under acidic conditions. Results: Optimal adsorption conditions for Ft were studied using response surface methodology (RSM), which suggested a buffer pH of 4.2 and an FBS dilution of 40%. However, increasing the pH to 5 resulted in a 28% increase in Ft recovery, although with a slight reduction in Ft purity to 88%. A scale-up to half a liter of FBS was performed using a 400 mL column. A single-step elution with 0.3 M NaCl was employed, yielding an Ft recovery of 90% with a purity greater than 82%. Conclusions: The purified Ft demonstrated biological activity as a growth promoter in MDBK cell culture when utilized in a serum-free culture medium. Full article

Background/Objective: Effective topical delivery of 4-phenylbutyric acid (4-PBA) for arsenical vesicant-induced skin injury requires nanocarrier systems that maintain physicochemical and chemical stability during extended storage. This study systematically evaluated the six-month stability of five 4-PBA-loaded micro/nanoparticulate formulations—chitosan nanoparticles (N31, N35), emulsomes (E2), microsponges (MSs), and PLGA nanoparticles (P1)—to identify lead candidates suitable for field deployment and foam integration. Methods: Formulations were subjected to ICH-accelerated stability testing at 25 °C/60% RH and 40 °C/75% RH, with monthly evaluation of particle size, polydispersity index, zeta potential, drug content by HPLC, and chemical/thermal stability by FTIR and DSC. Results: N31 demonstrated superior colloidal stability, maintaining particle size within acceptable limits at both conditions despite progressive surface charge neutralization. E2 showed consistent drug content retention and preserved chemical integrity, though moderate vesicle fusion occurred. MS underwent complete physical degradation at 40 °C within the first month, while P1 exhibited hydrolytic degradation with substantial drug loss. N35 showed severe aggregation indicating colloidal instability. Conclusions: N31 and E2 emerged as lead candidates: N31 is recommended for field deployment where environmental control is limited, while E2 is suitable for controlled storage settings prioritizing drug loading capacity. Full article

There is a growing global demand for cost-effective alternatives to high-priced biologic therapies, which has significantly accelerated the development of biosimilars and positioned them as sustainable and affordable treatment options. Biosimilars include therapeutic products such as monoclonal antibodies, soluble receptors, growth factors, and hormones that demonstrate comparable efficacy, safety, and quality to their reference biologics. By providing lower-cost alternatives, biosimilars play a vital role in bridging the affordability gap and expanding patient access to essential, life-saving treatments, particularly in low- and middle-income countries. This review focuses on current Good Manufacturing Practices (cGMPs) in biosimilar development, highlighting critical processes such as cell line engineering, glycosylation optimization, and bioprocess refinement aimed at improving cell culture productivity and product yield while ensuring consistent safety, efficacy, and quality across production batches. Advances in biotechnology, especially in proteomics and advanced analytical characterization, have improved understanding of cellular mechanisms influencing product quality and strengthened comparability with reference biologics. These scientific innovations have enhanced regulatory and clinical confidence, supporting wider acceptance and use amongst patients. In addition, this review examines the evolving global regulatory landscape governing biosimilars and its role in reducing development timelines and costs. Together, scientific innovation, standardized manufacturing practices, and harmonized regulatory frameworks foster competition, accelerate market entry, and ultimately help bridge the gap between innovation and affordability, ensuring equitable and sustainable global access to advanced biologic therapies. Full article

Dry eye disease is a common condition in which tear production or quality is insufficient to lubricate the eyes properly. Standard treatment usually involves lubricating eye drops. In this study, we assessed the human health risks, including both non-carcinogenic and carcinogenic effects, associated with long-term exposure to the chemical elements arsenic (As), cadmium (Cd), cobalt (Co), iron (Fe), nickel (Ni), lead (Pb), and zinc (Zn) in eye drops used in Brazil. The results indicated that the Co concentration (1.1048 mg/kg) in the eye drops sample 5 exceeded the limit established by the ICH Q3D (R2) guideline for parenteral products (0.5000 mg/kg). Additionally, As levels in eye drop samples 2, 8–10, 12, 13, and 16, as well as Cd levels in samples 2, 3, 8–10, and 12, exceeded the limits established by the Brazilian Pharmacopoeia for parenteral administration (0.0500–0.0532 mg/kg). The main health risk appears to come from oral exposure, as the drug can drain into the nasal cavity via the nasolacrimal duct and then be absorbed through the gastrointestinal tract. While none of the tested eye drops posed non-carcinogenic risks, carcinogenic risks from oral exposure to As and Cd were identified, with overall risk levels exceeding acceptable thresholds. These findings emphasize the need for strict regulation and continuous monitoring of these products to reduce health risks and prevent long-term damage. Full article

Medicine is accelerating rapidly, offering the advantages of site-specific delivery, minimized side effects, and improved treatment outcomes. A diverse array of chronic diseases, such as cancer, diabetes, asthma, myocardial infarction, and Alzheimer’s disease, are often accompanied by severe adverse effects and limited specificity, necessitating concentrated attention on targeted therapies. Recent advancements in molecular profiling and understanding of target pathways have enabled the identification of specific biomarkers and gene targets. These advancements have led to the development of targeted therapies that focus on the specific molecular alterations responsible for disease progression. Such therapies offer a more personalized and effective approach to treatment. This review focuses on the benefits of targeted therapies compared to traditional therapeutics and provides an overview of currently available targeted therapies for chronic diseases. By highlighting these advancements, the review aims to illustrate the progress in disease treatment towards more personalized approaches. The goal is to underscore how targeted therapies have evolved and how they represent a significant shift towards personalized therapy. Full article

Lecythidaceae species are known worldwide for their ability to produce edible nuts of high nutritional value, such as Brazil nuts, and are also used in traditional medicine in countries across America, Asia, and Africa. The potential of these species has aroused interest in their chemical composition, nutritional properties, and biological activities, with emphasis on anti-inflammatory and antinociceptive actions. The objective of this review was to summarize data regarding the anti-inflammatory and antinociceptive activities of Lecythidaceae species, identify the most promising bioactive agents, and elucidate their potential mechanisms of action. This integrative review was conducted by comprehensively searching the main electronic databases for scientific articles, with no restriction on publication date, that were available in full. Based on this survey, thirty-four articles were identified, covering twelve Lecythidaceae species with anti-inflammatory and antinociceptive actions evaluated in in vitro and in vivo models and randomized clinical trials. Studies encompass extracts, fractions, nuts, and isolated compounds, among which the extracts and fractions of Barringtonia angusta Kurz, Couroupita guianensis Aubl., Lecythis pisonis Cambess., and Petersianthus macrocarpus (P. Beauv.) Liben demonstrated potent inhibition of inflammatory mediators through suppression of gene expression in vitro and in vivo, acting via blockade of the nuclear factor kappa-light-chain-enhancer of activated B cells (KN-κB) signaling pathway. This finding highlights a relevant molecular mechanism by which Lecythidaceae species may exert their anti-inflammatory potential and supports further studies focused on isolating active fractions and elucidating possible synergistic effects. Ethnopharmacological and chemical composition data are also presented and discussed within the scope of their biological applications, highlighting the therapeutic potential of Lecythidaceae species and identifying promising candidates for future development of novel anti-inflammatory phytopharmaceuticals. Full article

The design and development of a robust and consistent manufacturing process for monoclonal antibodies (mAbs), augmented by advanced process analytics capabilities, is a key current focus area in the pharmaceutical industry. In this work, we describe the development and operationalization of multivariate statistical process monitoring (MSPM), a data-driven modelling approach, to monitor biopharmaceutical manufacturing processes. This approach helps in understanding the correlations between the various variables and is used for the detection of the deviations and anomalies that may indicate abnormalities or changes in the process compared to the historical dataspace. Therefore, MSPM enables early fault detection with a scope for preventative intervention and corrective actions. In this work, we will additionally cover the value of in silico data in the development of MSPM models, principal component analysis (PCA), and batch modelling methods, as well as refining and validating the models in real time. Full article

Dry eye disease (DED) is a multifactorial ocular surface disorder that significantly affects vision and quality of life. While artificial tears are the standard first-line therapy, their effectiveness is limited by the complex pathophysiology of DED. This study evaluated DayDrop^® Triple Action, a novel formulation combining hyaluronic acid (HA), ectoine, and carboxymethylcellulose (CMC), designed to enhance tear film stability and ocular surface protection. Physicochemical and rheological properties were assessed, including viscosity, pseudoplasticity, and viscoelastic behaviour under dynamic conditions, along with ectoine release over 24 h. An in vitro allergic conjunctivitis model using conjunctival fibroblasts exposed to a pro-allergic cytokine cocktail was employed to examine immunomodulatory effects. DayDrop^® Triple Action demonstrated high viscosity with pronounced pseudoplasticity and stable viscoelasticity, supporting improved mucoadhesion. The formulation provided sustained ectoine release and exhibited a positive immunomodulatory effect, likely linked to ectoine’s preferential hydration mechanism, which stabilizes membranes and reduces inflammatory signalling. These findings suggest that DayDrop^® Triple Action integrates viscoelastic optimization, osmoprotection, and targeted anti-inflammatory action, offering a promising non-pharmacological strategy for managing DED and allergic ocular surface disorders. Full article

The growing threat of Antimicrobial Resistance (AMR) demands innovative drug discovery, yet conventional 2D cell cultures fail to accurately mimic in vivo conditions, leading to high failure rates in preclinical studies. This review addresses the critical need for more physiologically relevant platforms by exploring recent advancements in bioengineered 3D tissue models for studying bacterial pathogenesis and antimicrobial drug discovery. We conducted a systematic search of peer-reviewed articles from 2015 to 2025 across PubMed, Scopus, and Web of Science, focusing on studies that used 3D models to investigate host–pathogen interactions or antimicrobial screening. Data on model types, biomaterials, fabrication techniques, and key findings were systematically charted to provide a comprehensive overview. Our findings reveal that a diverse range of biomaterials, including biopolymers and synthetic polymers, combined with advanced techniques like 3D bioprinting, are effectively used to create sophisticated tissue scaffolds. While these 3D models demonstrate clear superiority in mimicking biofilm properties and complex host–pathogen dynamics, our analysis identified a significant research gap: very few studies directly integrate these advanced bioengineered 3D models for high-throughput antimicrobial drug discovery. In conclusion, this review highlights the urgent need to bridge this disparity through increased research, standardization, and scalability in this critical interdisciplinary field, with the ultimate goal of accelerating the development of new therapeutics to combat AMR. Full article