Aurigene Pharmaceutical Services to expand biologics CDMO capacity with a new biomanufacturing facility

Aurigene Pharmaceutical Services Limited (Aurigene), a contract research, development, and manufacturing services organization and a step-down subsidiary of Dr. Reddy's Laboratories announces the construction of a state-of-the art development and manufacturing facility for therapeutic proteins, antibodies, and viral vectors.

As a first step of investment plan, Aurigene is investing $40m in an R&D and pilot scale facility at Genome Valley, a well-known Biotechnology Park in Hyderabad. This facility will meet the process development and clinical supply needs of global biotech companies. 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 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 high-quality services for antibodies, proteins, and viral vectors
• Dedicated scientific team with impeccable track-record of commercializing several biosimilars globally
• Global regulatory experience

Seamless 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 15kl and fill-finish capabilities making it possible to provide commercial quantities seamlessly. An additional fill-finish line is also 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.

Akhil Ravi, CEO, Aurigene Pharmaceutical Services Ltd., 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, Dr. Reddy’s Laboratories Ltd. added, “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”

About Aurigene Pharmaceutical Services Ltd.:

Aurigene Pharmaceutical Services is a leading contract research, development, and manufacturing organization (CDMO). Built on the legacy of accelerating innovation and backed by a vast CDMO pharma services experience in drug discovery, development and manufacturing of small and large molecules, our mission is to relentlessly work for the success of our clients and to build long-term relationships through a holistic approach to accelerate the journey of a molecule from the laboratory to market. By providing access to our resources, knowledge, and experience, we create success for our clients and - ultimately - patients. We offer integrated and standalone services for discovery chemistry, biotherapeutics discovery, discovery biology, development and manufacturing services for clinical phase I-III programs, regulatory submission batches and commercial manufacturing. A differentiating factor as a pharmaceutical contract manufacturing organization is the integrated API and formulations service that spans from key starting material, advanced intermediates, APIs to finished products such as oral solids, sterile products, nasal solutions etc. Our development and pharmaceutical API manufacturing services in India are complemented by cGMP commercial manufacturing facilities in the UK, Mexico, USA and India.

Aurigene is an independently managed step-down subsidiary of Dr. Reddy’s Laboratories Ltd.

SOURCE: Aurigene Pharmaceutical Services