Aurigene offers GLP and Non-GLP bioanalysis services for small molecules, peptides, biomarkers and complex molecules. Our Bioanalytical labs are well-equipped with high-end LC-MS/MS instruments, HPLCs or UPLCs with UV, PDA and fluorescence detectors. We have completed more than 200 GLP studies. We perform sample analysis of GLP PK or TK or TD studies. We do method validation as per regulatory requirement and ensure data quality and compliance.
Delivered 200+ GLP studies
Compound management and data automation
Quality and Accuracy
Regulatory submissions to US FDA, EMA, DGCI
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
Pharmaceutical development identifies and evaluates processes required to convert an NCE/drug substance into a drug product to deliver for its intended performance/purpose consistently. The pharmaceutical development process begins by measuring drug substance properties, identifying critical attributes of the drug product, checking absorption and stability profile of the drug and the most appropriate route of administration (e.g. oral, parenteral or topical).
Pharmaceutical development evaluation already at the early drug development stage is essential for selecting the right NCE and formulation to reduce the attrition rate in the late-stage development. These activities streamline efficacy/toxicology evaluations, allowing pharmacologically effective and developable molecules to reach the clinic and eventually patients.
The integration and close collaboration of preclinical and clinical development teams accelerate the FIH product development process by utilizing already available pre-formulation and bioavailability information and experience gained during preclinical formulation development. It also helps identify obstacles and apply the right formulation strategies early in the drug development process to avoid costly late-stage failures, significantly saving time and costs.
The rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the biological system site.
The movement of the drug in the biological system is influenced by many factors such as routes of administration, physicochemical drug properties, physiological factors (e.g. gastrointestinal pH, gastric emptying, small intestinal transit time, bile salt, absorption mechanism, food, metabolism), manufacturing technique, dosage form, and excipients. Understanding the interrelationship of these factors leads to biopharmaceutical and science-based drug product developments.
Incomplete oral absorption could be due to poor solubility, poor intestinal permeability, or presystemic metabolism. Incomplete oral bioavailability can often be surmounted through formulation efforts.
We can enhance the oral bioavailability through formulation efforts using solubilizers, pH adjustment, cosolvents, complexing agents, permeation enhancers, and enabling technologies (solid dispersion, particle size reduction and lipid-based drug delivery systems).
br>By identifying potential limiting steps for oral absorption of a compound (including dissolution, solubility, permeability, and limited metabolism process), understanding the physicochemical properties of a compound, recognizing physiological processes affecting drug absorption, along with awareness of a drug's BCS and DCS characteristics, pharmaceutical scientist can better predict formulation approaches that can maximize the drug’s bioavailability.
Formulations play a crucial role in assessing the biological properties of a molecule during drug discovery. Maximizing exposure is the primary objective of early animal experimentation to avoid discarding developable compounds with the desired pharmacologic properties.
Diversity in the physiology between various animal species, routes of administration, limited compound amount, and limitations posed by specific pharmacological models make formulation development much more challenging. Consistency in the exposure is also a key aspect as significant variations are observed in early NCE batches.
Additionally, preclinical tox (GLP) studies at early development, require NCE formulations that are simple, robust, provide ease of preparation, convenient to deliver to animals with minimal ancillary effects of vehicle and provide provision of high and dose-related systemic exposures in animals relative to anticipated human exposures to facilitate determination of tox profiles.
The selection and development of effective formulation and drug delivery strategies are essential to achieve this.
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