Advance your Biologics from
Concept to Commercial
25 Years of Experience
06 Products Commercialised
Explore our wide range of Biologics CDMO services
Aurigene Pharmaceutical Services Limited is a distinguished name in Large Molecule CDMO & therapeutic biologics. Aurigene is more focused on providing comprehensive end-to-end services for biologics, from concept to commercialisation.
With over 25 years of expertise, we excel in delivering recombinant products, including monoclonal antibodies, bi- & multi-specifics, cytokines, enzymes, and complex proteins.
Supported by state-of-the-art facilities and a global talent pool, Aurigene offers integrated discovery, process development and cGMP manufacturing services. As a subsidiary of Dr. Reddy’s Laboratories, we adhere to stringent quality and sustainability standards, making us a preferred partner for pharma and biotech companies worldwide.
Explore our wide range of Biologics CDMO services
Aurigene provides comprehensive mAb and protein therapeutics development with end-to-end capabilities, backed by our in-house physiochemical and bioanalytical expertise. With 25+ years of experience, our USA FDA & EMA-inspected CGMP facilities and global talent pool enable us to deliver robust, scalable and high-quality processes in cell culture and protein chemistry.
Comprehensive plasmid DNA production services, delivering both research-grade and GMP-ready plasmids. Our expertise spans small to large-scale production (0.1 mg to 1 g), ensuring high-quality yields. We support applications from cloning to gene therapy studies, with advanced fermentation, extraction, purification, and scale-up processes tailored to your needs.
Comprehensive Pharma Analytical Development and Manufacturing Services, offering physicochemical and biological characterisation. Backed by a strong protein chemistry background, we deliver accurate protein structure analysis, impurity detection and bioassay development. Our ALCOA+ driven quality systems, diverse technologies, and experienced scientific staff ensure high-quality, reliable analytical services.
Fill Finish Services for vials (liquid and lyophilized), pre-filled syringes, and autoinjectors. With over 10,000 sq.m of facilities, we handle high-accuracy, high-viscosity, low-volume filling using automated, end-to-end single-use systems. Our integrated quality management ensures compliance, proven by over 100 successful regulatory audits.
Why Aurigene Biologics CDMO Services?
25+ years of expertise & quality track record
- Commercialized 6 products in 30+ countries
- Global talent pool of scientists
- USA FDA, EMA inspected CGMP facility
- Proven, fully digital Quality Management System
State-of-the art facilities
- Pilot/clinical scale facility for CGMP & non-GMP supplies (200L reactors)
- Large scale commercial CGMP Drug Substance facility with single use bioreactors with capacity of ~25,000 L
- CGMP Drug Product filling vials, pre-filled syringes and cartridge or device for liquid and lyophilized formulations
Our Infrastructure
R and D centers
Aurigene Pharmaceutical Services is well-equipped with laboratories from discovery to clinical phase III for NCEs and NBEs. We operate two state-of-the-art R and D centers in Bangalore and Hyderabad. Our R and D centers are equipped with 60+ modular laboratories to handle highly potent substances, peptides, oligonucleotides etc. Our facility also has an extensive analytical center of excellence in addition to special purpose labs for safety assessment studies and polymorphism studies. Our best-in-class discovery biology services are supported by AAALAC accredited vivarium, BSL-2 compliant labs, in vivo facilities, GLP and other regulatory bodies accredited toxicology labs. Our state-of-the-art preclinical evaluation safety facility has been inspected by FCPSA Netherlands, DCGI and is annually inspected by National GLP Compliance Monitoring Authority (NGCMA). Our facility has also been inspected by the US FDA and the quality systems in this facility are in accordance with NGCMA and US FDA standards.
Manufacturing facilities
We have access to cGMP manufacturing facilities in the UK, Mexico and India. We operate thousands of kilo liters of API capacities that can handle various range of chemistries from regular small molecules, peptides, potent compounds, steroids, carbohydrates and pegylated drugs. In addition, we also operate formulation manufacturing plants that can handle various dosage forms including oral solids, parenteral and topical. Our facilities are designed modularly and offer flexibility of scale, enabling efficient operations. Our manufacturing facilities are regularly inspected by regulatory agencies.
ESG/Sustainability
Aurigene as a wholly owned subsidiary of Dr. Reddy’s Laboratories adopts the ESG goals of our parent company. Dr.Reddy’s has been committed to sustainability, diversity and equality for over two decades and has been honored with numerous accreditations and awards.
Awarded ‘Gold Medal’ status by EcoVadis, the global sustainability ratings agency, 2023
First Indian pharma firm to earn a place in the Standard & Poor Dow Jones Sustainability World Index (DJSI World) for 2023.
6th year in a row to be featured in the Bloomberg Gender-Equality Index (GEI) 2023.
Achieved “A” rating for supplier engagement, and for climate change & water security in 2023 by Carbon Disclosure Project (CDP)
Learn how our integrated expertise transforms your
biologics project from discovery phase to market readiness.
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