We aim at providing pharmaceutical stability solutions that include the study of product-related factors that influence the quality of a drug, such as the:
Interaction of an API with excipients Identification and prevention of degradation pathways in product Container closure systems
All stability samples are stored under controlled conditions such as incubators and stability chambers for accelerated or long-term or intermediate stability studies. The suitability of a drug substance or a drug product for its intended use is defined by attributes such as identity, strength, and purity.
In general, the drug substance and drug product are evaluated under storage conditions (with appropriate tolerances) that test their thermal stability and if applicable, their sensitivity to moisture. The storage conditions and the lengths of studies are defined by regulatory guidelines.
The intrinsic photostability characteristics of a new drug substance or drug product are assessed to demonstrate that light exposure does not result in unacceptable change. Usually, we conduct photostability testing for a single batch of the material selected as described under the selection of batches in the parent guideline. Under some circumstances, these studies can be repeated if certain variations and changes are made to the product (such as formulation and packaging). The repeat study helps us understand photostability characteristics determined at the time of initial filing and the type of variation and/or change made.
Our in-use stability testing services help to establish the period during which a multi-dose product can be used while retaining quality within an accepted specification once the container is opened. The continued integrity of products in multi-dose containers after the first opening is an important quality issue.
Capability to perform various forms of stability testing
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 More
JANUARY 04, 2021
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...Read More
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 More
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 More
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 More
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 More
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...Read More
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