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Discovery Biology Infrastructure Discovery Biology Infrastructure

Discovery Biology Infrastructure

Infrastructure to support standalone or integrated discovery biology services from target validation to IND.

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.
monitoringSystems
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