We operate our Discovery Biology services from our R and D centers in Hyderabad and Bangalore. The facilities are equipped to perform standalone services and integrated services across In vitro biology, DMPK, In vivo pharmacology, Microbiology and Toxicology services.
In vitro Biology
In vitro lab at Aurigene is equipped to perform standard and highly specialized biochemical and cell-based assays across different disease areas, multiple targets and a broad range of drug classes. In addition to the regular instruments like plate reader, biosafety cabinets, we have high end instruments for quantification of drug to protein interaction.
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DMPK
DMPK lab infrastructure covers a lab area of 10,000 sq.ft. with in vitro ADME and tissue culture labs. We operate GLP as well as Non-GLP bio analytical labs with high-end instruments including LC-MS/MS, Sciex API, Waters Xevo TQS, HPLCs/UFLCs with UV, PDA and fluorescence detectors. The in vivo and PK studies are conducted in AAALAC accredited animal facilities. In addition to the above, we also have a compound management and data automation system set up for DMPK.
In vivo Pharmacology
We have an AAALAC & CPCSEA accredited animal facility through which we can handle 600 rodents at any given time. We have more than 50 in vivo efficacy validated models available for testing. We provide PK/ PD correlation studies, biomarkers establishment studies across various targets and have advanced equipment for testing of compounds at early-stage drug discovery including anesthesia machine, electronic vonfrey, randall-sielto, capacitance meter, plethismomteter. We have completed 1000+ efficacy studies including submissions to the US FDA and DCGI.
Microbiology and testing
Our microbiology laboratory is biosafety Level 2 compliant, and it has been audited by US FDA in 2019 with Zero 483 observations. The labs are well equipped with all required instruments like biosafety cabinets, shaking incubator, carbon dioxide incubator, spectrophotometer, microscope and automatic microbial colony counter. We have a media laboratory where all types of microbiological media are prepared in-house using dehydrated powders.
Toxicology
We offer broad range of toxicology services from our GLP certified toxicology lab. We have an experience of conducting more than 9000 toxicity studies during the past 20 years. All toxicology studies are conducted in accordance with national and international test guidelines and in compliance with OECD principles of Good Laboratory Practice (GLP). The animal toxicity studies include short and long term non-GLP exploratory and GLP IND toxicity studies. The tests are carried out in rats and mice, and are maintained individually in ventilated cages. Our animal facility is AAALAC accredited. Our expert team of scientists are proficient in conducting assays such as bacterial reverse mutation test, in vivo and in vitro micronucleus test, in vivo and in vitro chromosomal aberration test. Clinical pathology laboratory is well equipped with fully automated analyzers for hematology, coagulation, clinical chemistry, and urine analysis. Histopathology laboratory is well equipped with state-of-the-art instruments to prepare good quality slides for various organs and tissues collected from experimental animals. These histopathology slides are examined microscopically by expert veterinary pathologists for safety evaluation of test articles. Apart, from standard toxicity assays, we also perform customized toxicity studies as proposed by the sponsors.
Animal Facility/Vivarium
To support our numerous discovery biology preclinical services, we have established and validated animal models for efficacy, pharmacokinetics and toxicology services. The vivarium is AAALAC accredited since June 2021 in appreciation of its animal welfare policies and for the care and use of laboratory animals We follow experimental protocols approved by Institutional Animal Ethics Committee (IAEC) / registered with Committee for Control and Supervision of Experiments on Animals (CPCSEA). The toxicology lab was established in the year 2002 and has been a OECD-GLP certified testing facility since 2003. Our vivarium has pollution board registered bio-waste disposable management systems and our institution has registered Institutional Biosafety committee ( IBSC) under department of Biotechnology, India .
Monitoring Systems
There are numerous monitoring systems available to help you understand experimental and other parameters.
- Rodents are procured from subsidiaries of Taconic and Charles River breeding facilities in Hyderabad. Select rodents and beagle dogs (Charles River and Harlan Laboratories) are bred in-house.
- The vivarium has restricted access control and CCTV monitoring system.
- Veterinary examination is regularly done, feed store area and four dog kennels are available.
- Physical examination of animals by veterinarian is regularly done.
- Health monitoring program as per FELASA guidelines is followed.
- Feed, water and bedding material analysis is done.
- Ethical efforts to avoid pain and distress to experimental animals is followed.
- Anesthesia and Euthanasia is given as per regulatory guidelines.
Resources
Continuous Flow Chemistry: A Game-Changer for Pharmaceutical Production
Fig 1:Schematic diagram of continuous flowFlow chemistry, also known as continuous flow chemistry, involves the continuous movement of reactants through a reactor to produce products. Unlike traditional batch chemistry, where reactants are mixed in a single vessel and processed in discrete batches, flow chemistry uses a continuous stream of reactants and intermed...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role in enabli...
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Anti-Infective Drug Discovery
Objective & Challenges: Objective was to identify an optimized anti-bacterial lead molecule with in vivo efficacy in relevant infection models an acceptable safety profile, and a patentable series. Challenge was to develop a more efficacious compound than the reference standard.Study design: Compounds were designed and synth...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2024
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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Formulation Development and Characterization of ION and PH Dual Activated Nasal IN-SITU Gel Containing Levodopa and Carbidopa for the treatment of Parkinson’s Disease
Parkinson's disease is a chronic neurodegenerative disorder of the brain that results in involuntary or uncontrolled movements, including tremors, rigidity, and impaired balance and coordination. This condition is characterized by the depletion of melanin-containing neurons that are responsible for pigmentation in the midbrain....
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