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Is the efficacy of your biologic product truly consistent? In biologics quality control—covering vaccines, antitoxins, monoclonal antibodies, and gene therapy products—the potency assay is a critical measure of biological activity. A well-designed and validated in vivo potency assay, complemented by a sensitive ELISA-based analytical system, forms the scientific foundation for demonstrating product efficacy, ensuring batch-to-batch consistency, and maintaining regulatory compliance. At Amaran Biotech, we understand the technical and biological challenges of developing robust mouse potency assays. Below are the three essential pillars for establishing a reliable potency evaluation framework—integrating ELISA analytics for quantitative precision and reproducibility. I. 🎯 Define the […]

Amaran Biotech, a leading Contract Development and Manufacturing Organization (CDMO) and advanced adjuvant provider, is continuing its commitment to quality excellence and operational efficiency through the implementation of a comprehensive electronic Quality Management System (eQMS), Simploud. This strategic move is designed to ensure the highest standards of product quality and patient safety, maintain rigorous regulatory compliance and audit readiness, enhance operational efficiency, reduce costs, and improve data integrity through paperless operation. Amaran Biotech is pleased to announce the successful rollout and go-live of the electronic Standard Operating Procedures (eSOP) module. This critical milestone signifies an important step in transitioning from […]

In the pharmaceutical sector, the pathway from innovative science to successful commercialization is governed by two inseparable forces: Scientific Progress and Regulatory Integrity. At Amaran Biotech, our Quality Assurance philosophy is proactive and deeply integrated. We employ a Quality by Design (QbD) approach to establish our systems, building quality into our processes from the earliest stages. Our entire framework is meticulously structured to exceed global Good Manufacturing Practice (GMP) requirements, creating a robust and scalable process ready for large-scale production. Furthermore, our commitment extends to rigorous continuous improvement. Through robust data analysis and a disciplined Corrective and Preventive Action (CAPA) […]

Purifying natural products is a highly specialized process that demands precision, scientific rigor, and strict quality control. Each stage must be justified not only for technical efficiency but also for regulatory compliance, risk mitigation, reproducibility, and cost-effectiveness. From active pharmaceutical ingredients (APIs) to high-value bioactives, every process step must align with Good Manufacturing Practice (cGMP) standards while maintaining scalability and production efficiency.  Below are Critical Steps in Natural Product Purification,  1. Raw Material Sourcing & Pre-treatment: Carefully selecting a stable, well-characterized source (plant, microorganism, marine organism, etc.) — and confirming species, origin, harvest time, and quality — ensures process stability. Pre-treatment […]

A High-Efficiency Alternative to GC-MS for Commercial-Scale Product Testing GC-MS is commonly used in early-stage development of pharmaceuticals and biotech products due to its high sensitivity and selectivity, particularly for limited, complex samples requiring structural identification. However, as the product moves into commercial-scale production, the high cost and operational complexity of GC-MS become burdensome for routine quality control. Amaran Biotech successfully assisted clients in converting their GC-MS method for residual solvent analysis to a more efficient and stable GC-FID method. Three Key Advantages of GC-FID Implementation:🔹 Enhanced Efficiency: Ideal for situations requiring a large number of repeated analyses, routine quality […]

To help the pharmaceutical industry meet upcoming regulatory requirements, we have successfully completed tooling for pre-filled syringes and are advancing to the next phase of testing preparation and service deployment. With USP <382> set to be implemented in December 1 2025, regulating the functional suitability of elastomeric components (such as plungers) in parenteral packaging and delivery systems. Testing services will be available shortly to support your compliance and quality assurance needs.

In 2025, Amaran Biotech has advanced its digital transformation, aligning with its vision of an AI-driven factory while adhering to GxP compliance standards. By implementing advanced technologies, including Asana, an electronic work /project collaboration system, electronic Quality Management Systems (eQMS), and Computerized Maintenance Management Systems (CMMS), Amaran has significantly enhanced operational efficiency and compliance.

Water for Injection (WFI) is a high-purity water essential to the pharmaceutical, biotech manufacturing, and related industries. Unlike regular purified water, WFI must meet the strictest pharmacopeial standards, such as those set by the United States Pharmacopeia (USP). As a fundamental carrier that may be directly injected into the human body, WFI requires significantly higher purity than industrial or potable water.

Amaran Biotech, through the close collaboration of its IT, Warehouse, and Quality Management (QM) departments, has successfully implemented a Warehouse Management System (WMS) developed by Unitech Electronics. This system enables fully digitized management for the warehouse operation and the DS and DP production lines of Amaran. As the core of manufacturing and supply chain operations, the WMS oversees the entire material management process—from raw materials to finished products—aiming to optimize product and material handling with high efficiency and low cost.

Lipid nanoparticles (LNPs) have revolutionized the delivery of mRNA therapeutics, providing stability, targeted delivery, and protection against degradation. From COVID-19 vaccines to cancer immunotherapies and genome editing, these systems represent a transformative shift in medicine.

QS-21, a saponin-derived adjuvant extracted from the bark of the Quillaja saponaria tree, has emerged as a key player in the field of vaccine development. Recognized for its ability to enhance immune responses, QS-21 is increasingly being explored as a vital component in vaccine formulations aimed at improving immunogenicity and overall effectiveness.

Based on PIC/S Annex 1 “Manufacture of Sterile Medicinal Products”, it is particularly important to ensure the quality and safety of sterile medicinal products throughout their manufacturing process. QC has played an essential role in the control and reduction of contamination by microorganisms, particulates and endotoxins/pyrogens.