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Journal of Pharmaceutical and BioTech Industry

Journal of Pharmaceutical and BioTech Industry is an international, peer-reviewed, open access journal committed to publishing research and development studies on all aspects of science, engineering, and technology applicable to the pharmaceutical and biotech industry sectors, published quarterly online by MDPI.

All Articles (26)

Biosimilars: Bridging the Gap in Biologics, Access, and Affordability

  • Afza Rizwan,
  • Karan Dubey and
  • Seema Bhatnagar
  • + 1 author

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.

5 February 2026

Comparative flowchart depicting comparative details of biopharmaceutical and biosimilar development.

Assessment of Human Health Risks from Exposure to Lubricating Eye Drops Used in the Treatment of Dry Eye Disease

  • Marcelo de Oliveira,
  • Elaine S. de Pádua Melo and
  • Valter Aragão do Nascimento
  • + 3 authors

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.

4 January 2026

Maximum concentration values of the elements quantified in lubricating eye drops used in Brazil.

The Future of Precision Medicine: Targeted Therapies, Personalized Medicine and Formulation Strategies

  • Gopinath Rongala,
  • Druva Sarika Rongala and
  • Appalaswamy Naidu Rongala

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.

8 December 2025

Overview of Key Molecular Targets and their Biomarker for various disease conditions.

Promising Anti-Inflammatory Species from the Lecythidaceae Family: An Integrative Review

  • Queli Cristina Fidelis,
  • Letícia Paula Benvindo Trajano and
  • Francisco Eduardo Aragão Catunda-Junior
  • + 7 authors

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.

10 November 2025

Flowchart according to PRISMA for selection of articles [17].

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J. Pharm. BioTech Ind. - ISSN 2813-9380