discovery toxicology - suven · discovery research. discovery toxicology. discovery research ....
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Discovery Research
Discovery Toxicology
Discovery Research Suven Life Sciences Ltd
Serene Chambers, Road-5, Avenue-7, Banjara Hills, Hyderabad-500034, India.
Contacts: [email protected], [email protected]
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Company Confidential Copyright © 2018 Suven Life Sciences Limited 2
Overview
S. No Title Page No
1 Discovery Tox Express 3
2 Animal Facility 4-5
3 Discovery Toxicology- Facilities 6-8
4 Discovery Toxicology- Capabilities 9-11
5 Quality Assurance 12
6 Contacts 14
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3Company Confidential Copyright © 2018 Suven Life Sciences Limited
Wherein toxicity studies are conducted on NCEs/NMEs at the early stage of discovery. The data is generated at extremely rapid pace with the highest quality and
scientific integrity to make a go/no-go decision.
Suven Life Sciences introduces the
4- Day Tox in 14 Days7- Day Tox in 17 Days
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4Company Confidential Copyright © 2018 Suven Life Sciences Limited
Rodent Facility
• Vivarium spreading over 15000 sft• Three floor facility with double
corridor system• House Rats, Mice, Guinea Pigs,
and Rabbits
Animal Facility
• Control environmental conditions
• HEPA filtered 100% clean air supply
• Individually ventilated cages
• Breeding nucleus from reputed vendors (CRL / Envigo)
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5Company Confidential Copyright © 2018 Suven Life Sciences Limited
Non-Rodent Facility (Beagle Dogs)
• Spreading over 5000 sft
• Capacity to accommodate ~ 100 dogs
• Single or group housing
• Sick isolation kennels
Animal Facility
• HEPA filtered 100% clean air supply• Control environmental conditions• Spacious play/exercise area• Separate rooms for formulation,
experiment, food preparation & storage
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6Company Confidential Copyright © 2018 Suven Life Sciences Limited 6
• Urine Analyzer• Clinical Chemistry Analyzer
Clinical Pathology Lab
• Hematology Analyzer• Coagulometer
Discovery Toxicology - Facilities
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7Company Confidential Copyright © 2018 Suven Life Sciences Limited
Histology Lab
• Automatic Tissue Processor• Embedding System
Discovery Toxicology - Facilities
• Microtome• Multi-stainer• Cover-slipper
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8Company Confidential Copyright © 2018 Suven Life Sciences Limited
Microscopy and Image Analysis
Discovery Toxicology - Facilities
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9Company Confidential Copyright © 2018 Suven Life Sciences Limited
In Vitro Toxicity studies Cyototoxicity assessment
MTT (Cellular Metabolic Activity) LDH (Lactate Dehydrogenase Activity) Trypan blue (Cell Membrane Integrity)
Test System: HepG2 (Human hepatocellular carcinoma) HEK293 (Human embryonic kidney)IMR32 (Human neuroblastoma)
Discovery Toxicology Capabilities
9
Phospholipidosis Fluorescent Microscopy Fluorometry (Fluorescence Plate Reader)
Test System: CHO-K1 (Chinese Hamster Ovary cell line) CHL/IU (Chinese Hamster Lung cell line)
T a m o x ife n A c e ta m in o p h e n C o m p o u n d -10
2 5
5 0
7 5
1 0 01 0 0 µ M
1 0 µ M
M T T A s s a y
1 µ M
% V
iabi
lity
T a m o x ife n A c e ta m in o p h e n C o m p o u n d -10
2 5
5 0
7 5
1 0 0 1 0 0 µ M 1 0 µ M
L D H A s s a y
1 µ M
% C
ell d
eath
T a m o x ife n A c e ta m in o p h e n C o m p o u n d -10
2 5
5 0
7 5
1 0 0 1 0 0 µ M 1 0 µ M
T ry p a n b lu e e x c lu s io n
1 µ M
% V
iabi
lity
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10Company Confidential Copyright © 2018 Suven Life Sciences Limited
In Vivo Toxicity studies Single dose studies
Repeat dose tox studies
Animal species: Mice, Rats, Rabbits, Guinea pigs
Routes of administration: oral, iv, im, sc, ip, dermal
Discovery Toxicology Capabilities
10
Custom design studies
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11Company Confidential Copyright © 2018 Suven Life Sciences Limited
Genetic Toxicity studies In vitro Genotoxicity studies
• Bacterial reverse mutation test (Ames test)• Chromosomal aberration test• Micronucleus test
Discovery Toxicology Capabilities
11
In vivo Genotoxicity studies
• Micronucleus test• Chromosomal aberration test
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12Company Confidential Copyright © 2018 Suven Life Sciences Limited
• Independent Quality Assurance team
• Quality System Procedures (QSP’s) for Quality System Management and Standard Operating
Procedures (SOP’s) for Operation, Calibration, Maintenance of Equipment's
• Accredited by ISO/IEC 17025:2005 Quality System since 2005
• Document and Data Control, Conducting Internal Audits, Study Specific Audits
• Dedicated Archive facility for the retention of the records
• Facility audited and approved by many global pharmaceutical companies and majority of
Indian Pharma Companies
• Integrity of studies is maintained by following critical components of GLP compliance like
SOP, test and control article handling, data handling, training documents, archives etc.
Quality Assurance
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13Company Confidential Copyright © 2018 Suven Life Sciences Limited
Advantages with Suven Discovery Toxicology
• Expertise in discovery research• Rapid turnaround time with quality results• Flexibility in study conduct as per Sponsor’s requirement• Follow GLP principles• Cost effective
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14Company Confidential Copyright © 2018 Suven Life Sciences Limited
Contacts:
Venkat JastiChairman & CEOE-mail: [email protected]
Ramakrishna NirogiVice President, Discovery ResearchE-mail: [email protected]