Aurigene Pharmaceutical Services expands biologics CDMO capacity
Aurigene Pharmaceutical Services, a contract research, development and manufacturing services organization and a step-down subsidiary of Dr. Reddy's Laboratories, announced the construction of a state-of-the-art development and manufacturing facility for therapeutic proteins, antibodies and viral vectors.
Aurigene is investing $40 million in an R&D and pilot-scale facility at Genome Valley, a well-known Biotechnology Park in Hyderabad, as a first step of the investment plan. This facility will meet global biotech companies' process development and clinical supply needs.
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The facility is based on a state-of-the-art design concept, allowing maximum flexibility for a multi-product, multi-platform offering across therapeutic proteins, antibodies and viral vectors. The facility is planned to be fully operational in the first half of 2024.This complements Aurigene’s strong foundation in biotherapeutics discovery, contributing to accelerating global R&D-driven (bio)pharma companies’ biologics journey to the market by:
- Offering end-to-end and services for antibodies, proteins and viral vectors;
- Dedicated scientific team with that will commercialize several biosimilars globally;
- Global regulatory experience; and
- Access to commercial manufacturing—ready to scale quickly.
The expansion provides global customers access to a dedicated team and modern labs, including a pilot facility. This offer is complemented by exclusive access to an established large-scale GMP manufacturing facility with a drug substance capacity of 15 kl and fill-finish capabilities, making it possible to provide commercial quantities seamlessly. An additional fill-finish line also is under construction to be validated before the end of 2024. With a strong track record of commercializing six biosimilars globally, the team is well-positioned to help clients bring their novel biologics drugs to patients faster, the company said.
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Akhil Ravi, CEO of Aurigene said, “We see an increased outsourcing demand from global biopharmaceutical companies. With this expansion in biotherapeutics CDMO, we will be positioned to provide integrated services from clinical research to commercial manufacturing for small and large molecules. Investing in emerging technologies and health solutions reinforces our aim to triple our existing reach to touch over 1.5 billion patients worldwide by 2030.”
Jayanth Sridhar, global head of biologics for Dr. Reddy’s said, “We are excited to expand our infrastructure in Hyderabad in our continuous efforts towards providing world class services to biotech companies worldwide. Our experience and fully integrated setup in developing biosimilars end to end, right from cell line development to process development, to scale up and commercial manufacturing for drug substance and drug product, provides us with comprehensive capabilities to offer fast solutions for our potential customers and clients. We wish to work with our customers in a variety of modalities and technologies to address the most pressing unmet needs.”