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Aurigene Biologics CRDMO Services: From Discovery to Commercialization
Aurigene Pharmaceutical Services is a leader in biologics, offering a comprehensive range of services from discovery to commercial manufacturing. With over 25 years of experience and a legacy of successfully commercializing biologic products in over 30 countries, we are trusted by innovators in the pharmaceutical and biopharmaceutical industries.
As a subsidiary of Dr. Reddy’s Laboratories, we leverage state-of-the-art facilities, a global talent pool, and a commitment to sustainability to ensure that your biologics are developed with the highest quality standards. Aurigene is the ideal partner for advancing biologic therapies from concept to market, offering cutting-edge discovery solutions and flexible, scalable CRDMO capabilities.
Explore our wide range of Biologics CDMO services
We provide comprehensive biologics discovery services that cover every stage of the early development process. Our expert teams specialize in recombinant protein therapeutics, with a focus on monoclonal antibodies (mAbs), bi-specifics and multi-specifics, cytokines, enzymes, and other complex proteins.
Our Discovery Capabilities Include:
- Monoclonal Antibodies & Multi-Specifics: Antibody generation, Hybridoma technologies, Single B-cell screening (B-CAD platform), Phage display and more.
- Antibody Drug Conjugates (ADC): Antibody, Linker and Payload synthesis, Conjugations & analysis etc.
- Custom Bioreagents: Tool antibodies, engineered cell lines, proteins & conjugates.
- In vitro Biology: Immuno-oncology, immunogenicity screening, effector functional analysis, potency & mechanistic assays.
- In vivo Services: Multiple animal and disease models, including AAALAC accredited vivarium.
- Advanced Modalities: mRNA, Viral vectors, CAR-T, and cell-mediated drug delivery.
- Immuno-fusion Molecules: Including immune cytokine and antibody-enzyme fusions.
Why Choose Aurigene for Discovery?
Proprietary High throughput platforms for accelerated timelines. Our B-cell cloning platform has a screening time of 10-12 days
Shipped to locations across North America in 3-4 business days
Deep expertise in discovering high affinity antibodies
Recombinant cell lines for wide protein classes ISO 9001 certified labs and AAALAC accredited vivariumWith the state-of-the-art facilities, Aurigene offers end-to-end services for biologics, from process development to clinical and commercial-scale manufacturing for monoclonal antibodies (mAbs), bi-specifics and multi-specifics. Our comprehensive capabilities are designed to meet the evolving needs of our Biopharma clients with the highest standards of quality and regulatory compliance.
Our CDMO Services Include:
- Cell Line Development - High-performing cell lines tailored to your product goals, giving you complete control and flexibility
Process Development & Optimization -
- Our advanced perfusion technology enables continuous cell retention and facilitates N-1 perfusion, high productivity harvest and seed train intensification to optimize growth & culture longevity for Monoclonal antibodies, Bi-specifics, Multi-specifics & Engineered proteins.
- We specialize in precision purification, utilizing high-throughput chromatography and advanced filtration systems to maintain cell viability
- Analytical Services: Established platform methodologies for monoclonal antibodies and mAb-like products expedite development and regulatory submissions, ensuring robust data packages that meet global standards
Manufacturing Services -
- Pilot/Clinical Scale Manufacturing: For toxicology/pre-clinical studies and small-scale batches.
- Drug Substance (DS): Our cGMP manufacturing unit which can scale up to 35KL hosts single-use systems, enabling a multi-product facility to minimize cross-contamination, ensure flexibility and deliver faster TAT
- Drug Product (DP): Liquid and lyophilized formulations, filling vials, pre-filled syringes, and cartridges.
Why choose Aurigene for your clinical & commercial supplies?
Over 25 years of deep scientific expertise in bioprocess manufacturing
Proficiency in developing multiple monoclonal & bi-specific assets
USFDA, ANVISA and EMA-inspected cGMP facilities.
Advanced digital Quality Management systems enabling real-time tracking, audit readiness, and seamless data managementOur 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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