Aragen Life Sciences, a contract research development and manufacturing organisation based in India, is building its first biologics manufacturing facility in Bangalore.
The first phase of the facility began operations in March 2024 and successfully completed its first small-scale manufacturing project of producing a novel anticancer monoclonal antibody (mAb) for a US-based company.
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The facility is used to develop and manufacture mAb, therapeutic proteins and fusion proteins, enhancing the company’s existing bioproduction capability in California, US.
An estimated investment of $30m will be made in the project and it is expected to hire 50 employees initially.
The investment is part of the company’s strategy to accelerate its US-based biologics business to offer integrated gene-to-GMP (good manufacturing practices) solutions to customers. It helps Aragen to cater to the growing demand for biopharmaceuticals, strengthening its position in the domestic and international markets.
The facility’s first manufacturing suite will open in the third quarter of 2025.
Aragen’s biologics manufacturing facility details
The state-of-the-art facility covers an area of approximately 160,000m²Ìý (1.72 million ft²Ìý), including process development laboratories, and multiple GMP manufacturing suites with supporting functions such as analytical and microbiology quality control labs.
It offers cell line development, upstream and downstream development, protein science and antibody discovery services, and enables GMP and non-GMP manufacturing.
The manufacturing suites will be equipped with two 500l sub-unit bioreactors, which can be further extended with two 2,000l bioreactors when required to maintain efficiency and high quality in the production processes.
The suites will enable intensified processing using advanced single-use bioreactors and downstream purification capability for a growing biologics customer base.
The single-use bioreactors capacities range from 50l to 2000l and offer integrated solutions covering various stages of the biologics development lifecycle, including process development, process validation, analytical development, pilot production, large-scale downstream manufacturing and stability services.
Infrastructure at Aragen’s Bangalore facility
The facility is equipped with the latest technologies, is designed to handle multiple products and can manufacture products with titres ranging from less than 1g/l to 12g/l.
The single-use platform enables easy, flexible and efficient multi-product operations. It has in-house capabilities for mAb and therapeutic protein manufacturing to accelerate clinical drug substance manufacturing.
A comprehensive quality management system has been implemented including paperless operations to assure 100% data traceability and integrity. This enables Aragen to deliver superior biopharmaceutical products and services to its global clientele.
The facility is designed to accommodate plasmid DNA, mRNA, cell and gene therapy, microbial manufacturing, and additional GMP manufacturing suites in the future as demand increases.
Marketing commentary on Aragen
Aragen, formerly known as GVK Biosciences, is powered by experienced scientists, well-validated cell line platforms and state-of-the-art facilities, which has propelled the company to complete more than 200 cell line development projects. More than 100 of these have progressed to the clinic following an investigational new drug application.
Four of Aragen’s cell lines are actively contributing to the production of marketed products in the biopharmaceutical industry. Aragen has introduced the optimised RapTr 2022 platform for cell line development. The platform can achieve titres up to 6g/l, reducing cell line development timelines by 33%, and accelerating the cell line engineering process, taking it from DNA transfection in host cell lines to the research cell bank within 18 weeks.
Aragen provides a variety of in vitro and in vivo services through its subsidiary Aragen Bioscience. The services include exploration, cell line development, manufacturing, characterisation and evaluation of efficacy in the development of biologics for both human and animal health. Its advanced research and development facilities are located in the San Francisco Bay area.
