Aragen Life Sciences, a contract research development and manufacturing organization based in India, will build its first biologics manufacturing facility in Bangalore, India.
The facility will be utilised to develop and manufacture monoclonal antibodies, 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. The facility is expected to begin operations in 2024 and will initially hire 50 employees.
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 will help Aragen to cater to the growing demand for biopharmaceuticals, strengthening its position in the domestic and international markets.
Details of Aragen’s biologics manufacturing facility
The state-of-the-art facility will cover an area of approximately 160,000m² (1.72 million square feet), including process development laboratories, and GMP manufacturing suites with supporting functions such as analytical and microbiology quality control labs.
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 single-use bioreactors and advanced downstream purification capabilities will enable intensified processing.
The facility will provide 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.
The process development laboratory is expected to be operational by late 2024 and the first manufacturing suite will open in the third quarter of 2025.
Infrastructure at Aragen’s Bangalore facility
The facility will be equipped with the latest technologies, is designed to handle multiple products and can manufacture products with titers ranging from less than 1g/l to 12g/l.
The single-use platform enables easy, flexible, and efficient multi-product operations. It will have in-house capabilities for monoclonal antibodies and therapeutic protein manufacturing to accelerate clinical drug substance manufacturing.
A comprehensive quality management system will be implemented including paperless operations to assure 100% data traceability and integrity. It will enable 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 a research and development solutions provider to the global life sciences industries.
It 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, with more than 100 of them progressing to the clinic following an investigational new drug (IND) 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 titers 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.
Through its subsidiary Aragen Bioscience, Aragen provides a variety of in vitro and in vivo services. These span the 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.
The company offers comprehensive end-to-end services encompassing cell line development, process development, analytical development, scale-up, manufacturing, and regulatory support, which enables seamless project management and faster time-to-market for clients.