At Aurigene services CDMO, we offer a truly integrated biologics manufacturing platform that covers both Drug Substance (DS) and Drug Product (DP) — supporting everything from early clinical development to commercial-scale production. Our facilities are built with advanced infrastructure, single-use technologies, and process intensification strategies that help speed up development timelines, meet global regulatory standards, and maintain consistent product quality. Whether you're working on monoclonal antibodies, fusion proteins, or other biologics, our team brings deep expertise in upstream and downstream processing, aseptic fill-finish, and regulatory readiness.
Drug Substance Manufacturing Excellence
- Scalable Capacity: Aurigene services operates with over 20KL of manufacturing volume, including multiple 1KL and 2KL single-use bioreactors, enabling flexible production across development stages.
- Process Intensification: We deploy perfusion-based upstream technologies to achieve high cell density and sustained productivity, optimizing yield and reducing footprint.
- Single-Use Systems: Our upstream operations utilize fully disposable bioreactor platforms, minimizing contamination risk and enabling rapid turnaround with simplified cleaning validation.
- Advanced Control: Integrated real-time monitoring and control systems ensure process consistency and performance optimization.
Downstream Purification with Single-Use Innovation
- High-Purity Recovery: Aurigene services downstream suites feature advanced chromatography and filtration technologies, including Protein A affinity, ion exchange, and ultrafiltration.
- Single-Use Support Equipment: Enables fast batch changeovers and low cross-contamination risk, ideal for multi-product environments.
- cGMP-Compliant Operations: All purification processes are executed under stringent regulatory standards to ensure product integrity and traceability.
Drug Product Manufacturing Capabilities
- Aseptic Fill-Finish: Aurigene services offers fill-finish services for vials, prefilled syringes, and autoinjectors, supported by automated filling lines and lyophilization capabilities.
- Sterility Assurance: Integrated visual inspection systems and single-use components ensure precision, sterility, and operational agility.
- Flexible Formats: Designed to meet diverse delivery needs across therapeutic areas.
Global-Ready Infrastructure
- EMA & FDA-Approved Facilities: Built to meet international regulatory standards, with validated cleanrooms, electronic batch records, and robust quality systems.
- Audit-Ready Compliance: Aurigene services ensures full traceability and readiness for global regulatory inspections.
Why choose Aurigene?
End-to-End CDMO Services
Expertise in Small & Large Molecules
Global Regulatory Compliance
State-of-the-Art Infrastructure
Accelerated Development Timelines
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Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Methoxy Polyethylene Glycol (m-PEGs)
Aurigene Pharmaceutical Services is a leader in the synthesis of activated MethoxyPolyethyleneGlycol(m-PEGs), With a comprehensive product range and customized services. ...
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Base mediated spirocyclization of quinazoline: one-step synthesis of spiro-isoindolinone dihydroquinazolinones
2020
A novel approach for the spiro-isoindolinone dihydroquinazolinones has been demonstrated from 2- aminobenzamide and 2-cyanomethyl benzoate in the presence of KHMDS as a base to get moderate yields. The reaction has been screened in various bases followed by solvents and a gram scale reaction has also been executed under the given conditions. Based on the controll...
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Ultrasound assisted rapid synthesis of mefenamic acid based indole derivatives under ligand free Cu-catalysis: Their pharmacological evaluation
2005
An improved and rapid synthesis of mefenamic acid based indole derivatives has been achieved via the ligand free Cu-catalyzed coupling-cyclization method under ultrasound irradiation. This simple, straightforward and inexpensive one-pot method involved the reaction of a terminal alkyne derived from mefenamic acid with 2- iodosulfanilides in the presence of CuI ...
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Formal synthesis of Cladospolide C & epi-Cladospolide C using R- (þ)-g-valerolactone as a chiral synthon
2005
The formal synthesis of Cladospolide-C and its analog is achieved by using enantiopure (R)-g evalerolactone 10. The significant points of this synthesis are the stereoselective dihydroxylation of a, bunsaturated ester 16 using Sharpless protocol, Wittig olefination of g evalerolactol 6 with triphenylphosphonium iodide salt 7, one pot selective oxidation ...
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Amberlite-15 promoted an unprecedented aza Michael rearrangement for one pot synthesis of dihydroquinazolinone compounds
2005
A new one pot multicomponent annulation strategy for the synthesis of various dihydroquinazolinone compounds has been developed using Amberlite-15 as a catalyst, giving good to moderate yields. In this reaction the substrate scope for amines and aldehydes was also investigated. The reaction has been checked on a large scale ...
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