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Small Molecules: Development

Small Molecules: Development

We are committed to provide high quality and flexible scale development services for small molecules.

At Aurigene, we have a well-experienced team that is skilled with global quality and regulatory guidelines to complement your projects with the right set of small molecules development activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We offer comprehensive process development solutions to identify and develop the most optimal process for your compounds including New Chemical Entity (NCE), advanced intermediates and Key Starting Materials (KSM).

We provide small molecules development services from our R and D center in Hyderabad. This facility handles process development and non-GMP supplies at a 0.5-kilogram to 2-kilogram scale and enables the tech transfer to GMP facilities for clinical supplies. This facility is equipped with 15 chemistry labs and an analytical center of excellence that is fully equipped for chromatography, characterization, spectroscopy and thermal analysis.

Our R and D center houses a dedicated high potent lab. The peptide labs are housed with manual and automatic synthesizers that can handle solid, liquid, and hybrid synthesis. The high potent lab can handle products with OEL <0.1 µg/m³. In addition, we operate 3 non-GMP kilo labs including a steroid line.

We also have labs that carry process safety and powder safety studies. Our crystallization and risk assessment lab carries out a comprehensive solid-form screening, crystallization, and development of API to meet the desired specifications including solvent screening, polymorph screening, solubility studies, crystallization studies, PAT studies, scale-up studies and particle size distribution.

Clinical and commercial supplies are enabled through our eight US FDA-inspected GMP facilities across India, UK and Mexico. The sites can handle various technology platforms and have a variety of unit operations to suit our customer’s unique development needs.

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JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

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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. ...

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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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