At APSL, manufacturing of both Drug Substance (DS) and Drug Product (DP) is done on-site. The manufacturing is supported by in-house physiochemical and bioanalytical development. The development and manufacturing are supported with utility blocks, warehouse spaces, and R&D labs. We are well equipped with WHO-GMP-qualified plants. We have GMP approvals from various leading agencies including PIC/S authorities. Our facility is well equipped with state-of-the-art robotics and high throughput instrumentations such as ClonePix, Octet, CEDEX, Maxcyte, and Ambr.
We have non-GMP manufacturing capability in the range of 50L – 200L and GMP manufacturing capability over a wide scale - 50L to 2,000L in single use bioreactors. We offer technological flexibility such as –
Batch Fed-batch Perfusion in single use/stainless-steel reactors
We provide an integrated approach to safety and quality management systems, leveraging a pan-organizational experience. We are a one-stop shop across the product life cycle – proof of concept to commercial.
We can support large scale vaccine manufacturing – 2x1KL per batch run in a single-use platform. Clinical and commercial manufacturing is done at 200L and 1000L scale with the ability to manufacture in stainless steel as well as single- use technology.
State-of-the-art cGMP viral vector manufacturing (scales up to 2 X 1000 L) facility is being commissioned and clinical grade rAAV production process optimization is under development. 10KL of cell culture manufacturing capacity with expansion initiatives under way to double capacity by setting up a new cell culture manufacturing plant, fill finish manufacturing plant, clinical material manufacturing plant, and supporting utilities.
We are committed to data integrity and reliability based on digital data recording in accordance with GAMP 5 requirements. We follow documentation and report writing to comply with regulatory filing with FDA, PMDA, and EMEA. Our development is supported by digital infrastructure.
Leading CDMO/CRO Company Aurigene Pharmaceutical Services
Aurigene Pharmaceutical Services Limited is a leading contract research, development and manufacturing organization (CDMO) providing end-to-end solutions. With a strong legacy of services in discovery, development and manufacturing we are ideally positioned
Know MoreLeading CDMO/CRO Company Aurigene Pharmaceutical Services
Aurigene Pharmaceutical Services Limited is a leading contract research, development and manufacturing organization (CDMO) providing end-to-end solutions. With a strong legacy of services in discovery, development and manufacturing we are ideally positioned
Know MoreConnect 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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