Scientific Hub of Applied Research in Emerging Medical science & technology

Gene Therapy & CAR-T Cell Products – Regulatory Framework

Rudroju Anusha, Akash Pujari — Mon, 06 Oct 2025 00:00:00 +0000

The advent of gene therapies and Chimeric Antigen Receptor (CAR)-T cell products represents a paradigm shift in modern medicine, offering curative potential for previously intractable genetic disorders and cancers. However, their complex biological nature, personalized manufacturing processes, and unique safety profiles, including risks of cytokine release syndrome and insertional mutagenesis, present significant regulatory challenges. This article provides a comprehensive analysis of the global regulatory frameworks governing these advanced therapies, comparing the expedited pathways and requirements of major agencies including the US FDA (e.g., RMAT designation), European EMA (e.g., ATMP Regulation, PRIME), Japan's PMDA (e.g., Sakigake), and emerging regulators in India (CDSCO) and China (NMPA). Through detailed case studies of landmark therapies such as the successful approvals of Luxturna and Kymriah, the commercial failure of Glybera, and the cost-effective model of India's indigenous NexCAR19 the review identifies critical success factors and common pitfalls in development and commercialization. It further explores the regulatory hurdles facing next-generation "off-the-shelf" allogeneic CAR-T therapies, which, while promising greater scalability and lower costs, introduce new concerns regarding graft-versus-host disease and gene-editing risks. The analysis concludes that the future of this field hinges on the development of adaptive, harmonized regulatory strategies that can keep pace with innovation. Key recommendations include the global standardization of Chemistry, Manufacturing, and Controls (CMC) requirements, the adoption of innovative clinical trial designs for small patient populations, and the implementation of outcome-based pricing models to ensure these groundbreaking treatments are not only safe and effective but also accessible and affordable worldwide.

HPLC in the Era of Biopharma: Advances in Column Chemistry, Automation and Data Analytics

Nagajyothi Bhavanam — Sun, 26 Oct 2025 00:00:00 +0000

High-performance liquid chromatography (HPLC) remains the cornerstone of analytical characterization in the biopharmaceutical industry, despite the proliferation of newer orthogonal and hyphenated techniques. The rapid expansion of biologics including monoclonal antibodies, peptides, oligonucleotides, viral vectors, and antibody–drug conjugates has necessitated substantial advances in chromatographic science. Innovations in column chemistry, encompassing superficially porous particles, hybrid organic–silica materials, and monolithic supports, have enhanced the resolution, sensitivity, and speed of biomolecule separations. Parallel to these material advancements, the integration of automation, artificial intelligence (AI), and advanced data analytics has transformed chromatographic workflows into highly intelligent, self-optimizing systems. Modern HPLC instruments are now embedded within digital ecosystems that comply with regulatory expectations, promote sustainability, and align with the principles of Quality-by-Design (QbD) and Process Analytical Technology (PAT). This review provides an in-depth analysis of the evolution of HPLC in the biopharmaceutical era, focusing on developments in column design, mobile-phase optimization, detection systems, and digital transformation. Furthermore, it discusses how emerging paradigms such as green chromatography, AI-driven decision support, and continuous analytics are redefining the future of pharmaceutical quality assurance. By integrating scientific innovation with data-driven intelligence, HPLC continues to serve as an indispensable analytical platform in biopharmaceutical discovery, process development, and regulatory compliance.

Improving Thermoregulation and Skin Integrity Monitoring for Neonates

Mon, 13 Oct 2025 00:00:00 +0000

Background: Thermoregulation and skin integrity are critical elements of neonatal safety and survival. Inconsistent monitoring of these parameters increases risks of hypothermia, hyperthermia, and skin breakdown in vulnerable neonates. Baseline audits in the NICU revealed 35% unstable temperatures, 28% skin integrity issues, and poor documentation compliance (<65%).

Methods: A quality improvement (QI) project was implemented using the FOCUS–PDCA framework from April to June 2025. Interventions included structured simulation-based training, implementation of a monitoring checklist, environmental control audits, and weekly compliance feedback. Data were analyzed using descriptive statistics.

Results: Post-implementation data demonstrated:

Stable body temperature in 92% of neonates (↑ 27 points).
Intact skin integrity in 91% of neonates (↑ 19 points).
Documentation compliance improved from 62% → 96%.
100% of NICU staff completed training and checklist use reached 89%.

Conclusion: The structured, multidisciplinary intervention significantly improved neonatal thermoregulation, skin integrity outcomes, and staff compliance. Sustaining gains requires continuous education, regular audits, and equipment maintenance.

Improving Patient Identification Compliance during Shift Handover in the Male Medical Ward

Angel G Joseph, Mubarak Hanyan Almasan, Hind Ali-Suwasis, Ali Abdullah Mohammed — Mon, 13 Oct 2025 00:00:00 +0000

Background: Accurate patient identification is essential to prevent medical errors, ensure patient safety, and improve continuity of care. Routine audits in the Male Medical Ward of Wadi Al-Dawaser General Hospital revealed poor compliance (62%) with patient identification protocols during shift handovers, resulting in misidentification incidents and near-miss events.

Objectives: To improve adherence to patient identification protocols during every shift handover.

To achieve ≥90% compliance rate in patient ID verification by July 2025.
To reduce misidentification-related incidents by at least 80%.

Methods: This quality improvement project followed the FOCUS–PDCA model. Interventions included the development of a structured handover checklist with embedded patient identification steps, focused staff training, visual reminders, and biweekly compliance audits. Data were collected through observational audits and analyzed using descriptive statistics.

Results: Patient identification compliance improved from 62% to 91% (+29%), misidentification incidents dropped from 5 to 1 per 1000 patients (−80%), and staff knowledge scores increased from 65% to 90% (+25%).

Conclusion: Structured handover checklists and regular audits significantly improved patient identification compliance, reduced misidentification risk, and fostered a culture of safety. Sustaining improvement requires continuous education, supervision, and reinforcement.

Green, Portable and Smart HPLC: Sustainable Workflows, Miniaturised Systems and AI-Driven Chromatography

Nagajyothi Bhavanam — Sun, 26 Oct 2025 00:00:00 +0000

High-performance liquid chromatography (HPLC) remains an indispensable analytical tool in pharmaceutical, environmental, and biochemical sciences. However, conventional HPLC workflows are increasingly challenged by high solvent consumption, energy demands, and environmental footprints. The paradigm of Green, Portable, and Smart HPLC has emerged as a transformative response aligning analytical chemistry with sustainability and digitalisation goals. The integration of green analytical chemistry (GAC) principles, miniaturised architectures, and artificial intelligence (AI)-driven automation has enabled low-solvent, high-efficiency, and intelligent chromatographic operations. This review comprehensively discusses the transition from traditional solvent-intensive systems to eco-efficient, portable, and digitally integrated chromatographic technologies. It critically examines solvent substitution strategies, environmentally benign stationary phases, micro- and nano-HPLC systems, and AI-enhanced method optimisation. Furthermore, the role of Internet of Things (IoT), cloud analytics, and hybrid HPLC-MS platforms in real-time monitoring and field deployment is explored. The review also analyses current regulatory validation frameworks, economic implications, and the evolving vision toward autonomous, self-learning chromatographic systems. Collectively, these innovations signify a paradigm shift toward sustainable and intelligent HPLC, harmonising analytical excellence with environmental stewardship and operational efficiency.

Characterization of Griseofulvin Niosomes via Thin Film Hydration Technique

A. Sambasiva Rao, Ramesh Babu Janga, Vadlamudi Bhumika, B. Sudheer — Fri, 31 Oct 2025 00:00:00 +0000

Griseofulvin, a potent antifungal drug, suffers from poor solubility and low oral bioavailability, necessitating advanced delivery approaches. In this study, eighteen niosomal formulations were prepared using the thin-film hydration method by varying surfactant type, surfactant-to-cholesterol ratios, and Stearylamine levels. Tween-60-based formulations showed superior performance, with Formulation F18 (Tween-60: Cholesterol 2:1, 0.75% Stearylamine) emerging as the optimized system. F18 achieved the highest entrapment efficiency (72.73%), smallest vesicle size (3.38 µm), and near-complete sustained release (94.86% in 24 hrs). Release kinetics followed the Korsmeyer–Peppas model, confirming a diffusion-controlled, non-Fickian mechanism. Stability studies demonstrated that F18 remained physically and functionally stable for three months at both refrigerated and room temperature conditions. Overall, niosomal encapsulation particularly the optimized F18 offers a promising strategy to enhance the solubility, stability, and controlled delivery of Griseofulvin, potentially improving its therapeutic efficacy.