State-of-the-art GLP Standard in vivo Laboratory for Drug Discovery and Development
Overview
Our state-of-the-art GLP Standard in vivo Laboratory (Animal House) was established at International Institute of Innovation and Technology, Newtown for the purpose of conducting preclinical (Animal) or nonclinical studies for the Drug Discovery and Drug development on GLP Mode, which is requires for the Investigational New Drug (IND) application to the regulatory agencies. This is well equipped, high standard barrier facility to provide sufficient space for the separation of activities (total area: 840 Sq.ft.) and capable to conduct number of parallel animal studies. It fulfills the requirements of clean room concept and standards of international and national regulatory agency GLP and CPCSEA.
Our aim to facilitate therapeutic area specific animal models for drug discovery for various disease like cancer, Sickle cell Anemia, Pain, inflammation, Arthritic, Alzheimer’s etc.
The Animal House (AH) project is the backbone of research activities of Drug Discovery of International Institute of Innovation and Technology (I3T). It maintains and provides various species and strains of quality animals to researchers of Institute. Annually, around 60 rodents are reared in the Animal House, out of which around 30 rodents are put to actual research use by scientists. The AH has its own institutional Animal Ethics Committee constituted specifically to address scientific and ethical considerations of animal use for research, and this has been in existence since 2022. The AH is also registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment and Forests, Government of India for breeding and conducting experiment on small animals.
The chief mandate of the AH is to maintain different strains of mice, rats and zebrafish, and perform collaborative research.
Main Features
- State of the art facility for the purpose of conducting preclinical (Animal) studies on GLP Mode. This is well equipped high barrier facility and it maintain separation of Activates as per compliance of FDA GLP 21CFR PART 58 & 21 CFR Part 11 for equipments etc. Compliance as per GLP, FDA, and CPCSEA.
- Aims to strengthen in-house IND Enabling studies for Drug Development
- Aim to facilitate therapeutic area specific animal models for drug discovery(cancer, Sickle cell Anemia, Pain, inflammation, Arthritic, Alzheimer’s etc)
- Clean room concept followed
- Sufficient space for number of parallel studies at a time .
- Animal holding Capacity is aprox.3000mice/ 500Rats in IVC’s.
The Facility Breeds and Supplies the Following Species and Strains of Animals
Species
Strains
Status
Mouse
BALB/c mice
Outbred
Rat
Wistar
Outbred
Zebrafish
Transgenic Lines
Outbred
GLP Standard in vivo Laboratory (Animal House)
GLP Standard In vivo Laboratory will be functional very soon to conduct regulatory studies for drug Development as per FDA and CPCSEA for animal experimentation.
GLP Standard in vivo Laboratory
- For the purpose of Drug Development under strict GLP guidelines
- As per Regulatory and FDA requirements
- In Compliance of for GLP (National GLP Programme),FDA, and other Accreditations
- To follow CPCSEA guidelines
- To produce specific pathogen free (SPF) to germ free laboratory animals in this in vivo laboratory (Animal house)