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
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.
Learning Resources
JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence bypass central thymic tolerance. The success of immune checkpoint blockade...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...
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August 28, 2020
Revisiting the reaction of b-chloroacroleins with 2-aminophenol: a new observation
The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...
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January 31, 2025
Development and assessment of a Bcs class II - SGLT2 (Sodium Glucose Cotransporter 2) inhibitor drug in the form of solid lipid Nanoparticles by selecting different lipids, co-surfactants, and manufacturing techniques
Drug Delivery System (DDS) has been used successfully in the past few decades to cure illnesses and enhance health because of its improved systemic circulation and ability to regulate the drug's pharmacological action. As pharmacology and pharmacokinetics advanced, the idea of controlled release emerged, demonstrating the significance of drug release in assessing...
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January 31, 2025
Development of novel paullone-based PROTACs as anticancer agents
Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
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March 13, 2025
Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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