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
OCTOBER 01, 2024
PROTACs: Research for a life without cancer
PROTACs: Proteolysis-targeting chimeras (PROTACs) are a rapidly evolving field with promising applications in cancer, neurodegenerative diseases, and other conditions where the regulation of protein levels is crucial. PROTACs are a novel class of small molecules designed to target specific proteins for degradation by the ubiquitin-proteasome sys...
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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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Case study: Tackling CYP 2C9 inhibition challenges
The Problem: Active compounds in a project were found to be highly potent inhibitors of CYP 2C9 The compounds selectively inhibited CYP 2C9 with IC50 values <100 nM There was no considerable inhibition of the other CYP isoforms Our Mitigation Approach: CYP 2C9 inhibition data was generated for a larger set of co...
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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2022
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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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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