As an integrated part of our formulation services, the preformulation studies, cover the assessment of a wide range of physical and chemical properties, which are critical to establishing the ideal formulation and delivery method for your lead candidates. The knowledge of various parameters based on regulatory and client-specific requirements is essential to formulate a high-quality drug product to satisfy your scientific requirements.
Experience with various characterization techniques
US FDA -inspected labs with advanced instrumentation
Understanding of various regulatory and pharmacopeial requirements
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
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
Formulation development is a part of the drug product development process where the drug substance is combined with suitable excipients and processed to produce stable drug products such as tablets, capsules, injectables, topical cream/gel.
The formulation in pharmaceuticals is a process where the drug substance/API is mixed with an excipient to form a final drug product by considering the particle size, pH, stability, polymorphism, and solubility. It helps to decide the most optimal delivery mode such as oral, parenteral, pulmonary, nasal, topical, ophthalmic or rectal.
Drug formulation is the process where a drug substance/ Active Pharmaceutical Ingredient (API) is converted into a final human consumable oral, parenteral, pulmonary, nasal, topical, ophthalmic, or rectal formulation to treat diseases.
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