At Aurigene Pharmaceutical Services, manufacturing of both Drug Substance (DS) and Drug Product (DP) are done on site. Clinical and commercial manufacturing of DS is done at 200L and 1000L scale with the ability to manufacture in stainless steel as well as single use technology. Integrated fill finish line can package the product in vials, PFS and cartridges.
The manufacturing is supported by in house physiochemical and bio analytical development. The development and manufacturing is supported with utility blocks, warehouse spaces and R and 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 facilities and high throughput instrumentations like ClonePix, Octet, CEDEX, Maxcyte, Ambr etc.
For Faster Execution of Engineering Batches
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 – Batch, Fed Batch, Perfusion in single use or stainless-steel reactors.
Manufacturing Systems
We provide Integrated approach to Safety and Quality management systems, leveraging a pan- organizational experience.
Aurigene is one stop shop across the product fife cycle – proof of concept to commercial. We can support large scale vaccine manufacturing – 2x1KL per batch run in single use platform.
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.
Resources
SEPTEMBER 04, 2023
Why meet us at CPHI Barcelona?
Discover the Opportunities: Visit Aurigene Pharmaceutical Services at CPHI BarcelonaThe Contract Research, Development and Manufacturing Organization (CRDMO) industry is a dynamic and rapidly evolving sector emerging as it plays a vital role in providing a wide range of services enabling drug companies to bring their products to market efficiently and effectively...
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Immuno Oncology - Therapies and Challenges
With more than 200 distinct cancer types recognized and steady increase in cancer incidence rates, the fight with cancer takes a new shape with each emerging decade. First was surgery, followed by radiotherapy and chemotherapy. The fourth one was targeted cancer therapeutics, also known as precision therapies. Precision therapies were established with the discove...
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Anti-Infective Drug Discovery
Objective & Challenges: Objective was to identify an optimized anti-bacterial lead molecule with in vivo efficacy in relevant infection models an acceptable safety profile, and a patentable series. Challenge was to develop a more efficacious compound than the reference standard.Study design: Compounds were designed and synth...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2023
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
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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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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2005
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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Simple and efficient synthesis of imidazoquinoxalines and spiroquinoxalinones via pictect-spengler reaction using Wang resin, Synthetic Communications
2005
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...
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