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 analytical activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We plan the analytical strategy based on the project lifecycle and customer needs. We have capabilities across method verification, development, validation and impurity profiling that includes isolation, identification & characterization and assessment of nitrosamine or other genotoxic impurities. We also conduct stability studies as per ICH guidelines.
Mass spectrometer (LC-MS and HR-MS)
For early phase projects, we develop analytical methods in hand-in-hand with the process development program. For critical quality attributes of the final product such as assay, related substances, and residual solvents analytical methods are verified. Our standard analytical method verification procedures check LOD, LOQ, linearity, precision, specificity, accuracy, robustness, solution stability and mobile phase stability. Along with these verifications, fit-for-purpose analytical methods for testing raw materials, in-process controls, and intermediate analysis are developed. Post mapping of equipment at the manufacturing facility, an appropriate residue method is also developed and validated. We generate and qualify the appropriate quantity of reference standards to support the analysis and method transfers.
We perform method validation as per the internal SOP of Aurigene against the predefined specification. The method will be validated as per ICH guidelines for parameters like LOD, LOQ, linearity, repeatability, recovery, solution stability, specificity, precision, accuracy, robustness and mobile phase stability. Analytical activities also depend on whether we are working on intermediates, RSM or the final API.
We perform analytical validation in compliance with the Pharmacopoeia, current Good Manufacturing Practices (cGMP) and ICH requirements as per customer needs. Following are the salient features of our method validation activities:
We perform stability studies for developmental APIs, intermediates, RSMs and drug products.
We have the stability chambers, refrigerator and deep fridge storage suiting to requirements of different climatic zone.
Expertise in global quality & regulatory guidelines
Phase appropriate standard operating procedures
Dedicated infrastructure
Breadth of analytical services
Expertise in the niche analytical requirements for various technology classes
JUNE 28, 2022
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...
Read MoreBuilding 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...
Read MoreWe 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 More2023
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 ...
Read More2021
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 ...
Read More2021
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. ...
Read More2021
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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