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.
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Resources
JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
Neoantigen specific T cells for cellular 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...
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...
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Technology meets sustainability - How a complex API development process goes green
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...
Read MoreAlternate 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.
2021
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
2021
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
2021
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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