Krish Biotech Research Pvt. Ltd. (KBRPL)
…is an independent research based organization promoted by the Krishi Rasayan Group. The state-of-the-art laboratory of KBRPL is spread over nine-thousand square meter of area, established at Kalyani near Kolkata, India. It is well recognized by national and international regulatory authorities and clients. KBRPL is providing integrated discovery, development & regulatory services, across the agrochemical, industrial chemical, pharmaceutical and medical device industries.
The Facility of the KBRPL
…is well equipped to provide analytical chemistry, toxicology and pharmacology services. The laboratories of analytical, wet & residue chemistry, genetic toxicology, eco toxicology, inhalation toxicology, clinical chemistry, histopathology and pharmacology are adequately spaced and equipped with advanced instruments. There is also a huge animal facility with 40 animal experimental rooms. There is a cold room facility with two chambers of different temperature ranges that also accommodate residue samples and other temperature sensitive items with adequate separation.
Quality and Commitment at KBRPL
…has been certified for ISO-17025:2005 by NABL and OECD GLP by the National GLP Compliance Monitoring Authority. The quality assurance team is focused and committed on ensuring that the highest quality standards are set and maintained.
Safety and Security at the Company
…follows a high standard of safety procedures and provides a safe working environment to all its employees and is well compliant with national and state regulations. The facility is under CCTV surveillance along with 24×7 security. Access to the facility is controlled by access data acquisition and control system monitoring.
Organization and Personnel at the Testing Facility
…has a well-defined organizational structure controlled by test facility management. Each function is taken care by the head of the department/section. KBRPL has a pool of well-qualified and experienced scientists to carry out the experiments efficiently with the utmost precision.
Ethics and Animal Welfare is Monitored
…by the Institutional Animal Ethics Committee (IAEC), and the committee ensures benevolent and justified use of animals for research. The animal facility is registered for experimentation and breeding under the CPCSEA, under the Ministry of Environment & Forests, Govt. of India.
Impurity Profiling & Five Batch Analysis
- Pre-screening using HPLC-DAD, GC-MS/MS, LC-MS/MS
- Method development & validation & for impurity analysis (SANCO)
- Preparation/procurement of active as well as impurity standards
- Analysis of five different production batches for active & impurities (>0.06%)
- Additional analysis – moisture content, inorganic impurities, acetone insoluble, etc.
- Establishment of mass balance (98-102%) as per EU/SINDAG/SENASA
Physical-Chemical Property Testing
- For technical grade active ingredient-physical state, color, odor, melting point, boiling point, vapor pressure, solubility, partition coefficient, density, dissociation constant, surface tension, viscosity, flashpoint/flammability, chemical composition, chemical equivalence, pH, etc.
- For formulated products – appearance, bulk density, wet-ability, suspense-ability, suspension stability, emulsion stability, wet & dry sieve test, solution stability, surface tension, viscosity, foam-ability, dustiness/fineness, storage stability (54 & 0 degrees Celsius), container performance test, etc.
- Persistence and dissipation in soil, plant, and water
- Harvest residue analysis for active and significant degraded products
- Method development and validation for residue analysis
- Kinetics & half-life in water (different pH & temperature) & soil (4 type) in laboratory
Major Analytical Equipment
- GC with FID: varian, agilent
- GC-MS/MS (Ion Trap & TQD): varian, agilent
- HPLC-DAD (3D analysis & peak purity), UV-VIS: waters, shimadzu
- LC-MS/MS (Triple quadra pole w/linear ion trap): ABSciex viscometer tensiometer: lauda
- Melting/boiling point apparatus: Buchii
- FT-IR & UV-VIS Spectrophotometer: Perkin Elmer, etc.
- Acute six pack studies (oral, dermal, inhalation, eye irritation, skin sensitization and PSI)
- Acute toxicity studies with different routes (oral, ip, im, iv)
- Synergism & potentiality study in rats
- Sub-acute toxicity studies in rats and mice (oral, inhalation, dermal)
- Bacterial reverse mutation (ames) test
- Chromosome aberration test (in vitro and in vivo)
- Micro-nucleus test (in vitro and in vivo)
Reproduction and Developmental Toxicity Studies
- Reproduction toxicity studies (male fertility and segment I studies) in rats
- Teratology studies (segment II-embryo-fetal development) in rats & rabbits
- Pre & post natal development studies (segment III), multi-generation studies in rats
- Alga growth inhibition test
- Daphnia acute immobilization test
- Acute toxicity test on fish (common carp, zebrafish and rainbow trout, etc.)
- Acute toxicity studies on honeybees (oral and contact) and on silkworm
- Earthworm acute toxicity tests
- Avian acute oral and dietary toxicity test (chicken, mallard, japanese quail, and pigeon)
- Silkworm acute toxicity test
ANIMAL FACILITY DISCLAIMER
Krish Biotech Research Private Limited has a large animal facility with 40 animal experimental rooms, equipped with HVAC system to control and maintain the environmental conditions as per the requirements of the national and international animal welfare authorities. They have our own breeding facility for all experimental animals.
- KBRPL has expanded its horizons by initiating the drug discovery efforts in areas that have scientific and commercial promise: metabolic disorders, oncology, immunology, pain, and inflammation.
- Following facilities are also available for contract research
Preclinical Efficacy Models Covering These Areas:
- Pain, inflammation, and immunology – SNL induced cold pain, psoriasis, arthritis in DBA1/J mice
- Asthma and COPD – Ovalbumin – induced asthma in BALB/c mice, LPS – induced neutrophilia in rats
- Metabolic disorders – OGTT, euglycemic clamp, DIO mice for diabetes, obesity, NAFLD, MCD – induce NASH model in mice
- GIT – Ulcer/colitis models
- Custom designed efficacy models from other therapeutic areas can also be taken up
- GLP bioanalysis, toxicokinetics, in vitro assays [cyp inhibition, caco2, and parallel artificial membrane permeability assay (PAMPA), liver microsome stability (multiple species), stability in S9 fraction, protein binding]
End to End Service for Product Registration Globally
- Data generation from relevant experiments under OECD GLP as per CIB & RC guidelines
- Preparation of related documents, dossier submission and close monitoring with regulatory agencies
- CIB & RC, Ministry of Agriculture, Government of India
- Provisional registration – 9 (3B)
- Original registration – 9 (3)
- Repeat registration – 9 (4)
- Dedicated regulatory team of experts and consultants
- Multiple products submitted in different countries