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.
Resources
FEBRUARY 25, 2025
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Familiarization, process optimization, and cGMP manufacturing and supply of 30.0 kg of a Bioactive Nucleotide (NAD Booster)
Background: A US-based biopharmaceutical company approached Aurigene Pharmaceutical Services for the familiarization, process development, and cGMP manufacturing and supply of 30.0 kg Nucleotide product (NAD booster) for phase-appropriate studies. The synthesis of the desired product involves three linear stages, which starts with reaction of a pentose...
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Identification of Degradants of Thermal and Oxidation Stress Studies of Empagliflozin and Linagliptin Tablets by HPLC-PDA and LC-MS Instrumental Techniques
2022
Objective of the manuscript is to identify the degradants observed in the thermal and oxidation degradation sample of Empagliflozin and Linagliptin tablets by using LC-MS and HPLC-PDA instrumental techniques. Thermal and oxidation degradation samples were injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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