integrated discovery, development and regulatory services · potency testing immunogenicity...
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BIONEEDS
Integrated Discovery, Development and Regulatory Services
Pharmaceuticals
Biopharmaceuticals
Medical Devices
Cosmetics
Agrochemicals
Nutraceuticals / Herbals
Chemistry Services
Drug Testing Lab
Internationally acclaimed Contract Research Organization
World class laboratories with cutting edge technology
Comprehensive understanding of global regulatory norms (USFDA, EPA,
OECD, EEC, MAFF, EMEA, MHRA, ANVISA, DCGI, CIBRC, RCGM)
Best talent pool from the industry with extensive experience and expertise
Outstanding customer services & commitment to scientific excellence and
quality through best in class services
Telephone: +91 816-221440 | Mobile no.: +91 98444 57677
PHARMACEUTICALS /
HERBALS /
NUTRACEUTICALS
CHEMISTRY SERVICES
AGROCHEMICALS /
INDUSTRIAL
CHEMICALS
MEDICAL DEVICES
BIOLOGICS /
BIOSIMILARS /
BIOPHARMACEUTICALS /
VACCINES
ALTERNATIVES TO
ANIMAL STUDIES
BIONEEDS
ABOUT US
BIONEEDS INDIA PRIVATE LIMITED is a Bangalore based Contract
Research Organization providing Integrated Discovery, Development &
Regulatory Services to Pharmaceutical, Biopharmaceutical,
Agrochemical, Industrial chemical, Herbal / Nutraceutical & Medical
device companies.
Accreditations / Certifications
National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India
Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forests and
Climate Change, GOI.
State Drug Controller as a Government approved Drug Testing Laboratory for carrying out tests on Drugs / Cosmetics and Raw
Materials used in their manufacture on behalf of licensees for manufacture for sale of Drugs / Cosmetics
Review Committee on Genetic Manipulation (RCGM), department of biotechnology, GOI to conduct experiments on animals for DNA
or Genetically modified resources
Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)
Bioneeds’ in-house R&D unit is recognised by Department of Scientific & Industrial Research (DSIR)
USFDA audited laboratory with no 483
ISO 17025 Accreditation from NABL (National Accreditation Board for Testing and Calibration Laboratories) for Biological and
Chemical Testing
Approved by CIB & RC (Central Insecticides Board & Registration Committee) Government of India
State-of-the-art Facilities Best-in-class infrastructure in a 2,50,000 sq.ft. built-up area equipped
with state-of-the-art facilities
Vivarium with 85 exclusive animal rooms built as per international
standards
Cutting edge drug discovery & development labs to support medicinal
chemistry, biology, In vivo pharmacology, toxicology, custom synthesis,
process R&D, cGMP manufacturing, formulation & analytical
development services
ADME PK / In vivo & In vitro
Proof of Concept
Efficacy
Toxicology
Physicochemical
Batch Release Testing
Safety Pharmacology
PHARMACEUTICALS / HERBALS /NUTRACEUTICALS
ICHSchedule YOECDFDA
Menotropin - FSH / LH Activity
Human Chorionic Gonadotropin
Estrogenic Activity
Follitropin, Residual LH Activity
Erythropoietin Alfa (EPO)
Insulin Assays
Rabbit Pyrogen Testing
Endotoxin Testing
Abnormal Toxicity
Sterility Tests
Test for Microbial Contamination
Microbiological Assay of Antibiotics
Immunogenicity Tests (for HIV
Antigens, Hepatitis Antigens etc)
Efficacy of Antimicrobial Preservation
Test for Histamine
Specific Activities
BIOASSAYS
VACCINES
Potency Testing
Immunogenicity
Toxicology
Batch Release Test
Dose Stability
Efficacy Test
Endotoxins
Abnormal Toxicity
Sterility
Pyrogens
Physicochemical
IP, BPEP, USPJP, OECDSchedule YWHO
Medicinal Chemistry: Generation of Hits & Transforming Hits
into Leads Lead optimization & Support for Drug
Candidate Nomination Library Synthesis Custom Synthesis: (From mg to multi kg scale) New Chemical Entities (NCEs)
Heterocyclic Building Blocks &
Scaffolds
Complex Molecules & Prodrugs
Key Raw Materials, Advanced
Intermediates etc.
Impurities & Stable Metabolites –
Support in Identification &
Characterization
Preparation / Isolation, Qualification
& Supply
Working / Reference Standard –
Preparation, Qualification & Supply
Library Synthesis Drug Development: Process Development & Optimization
of NCEs Forms Selection Material Generation as Required for
Pre-clinical (non-clinical) Studies Phys-Chem Studies Method Development & Validation Qualification of Standards Forced Degradation Stability StudiesProcess Research: Expertise in Demonstrating Quality
Process Research for APIs (Active Pharma Ingredients) & AIs (Active Ingredients)
Route Scouting, Non-infringing Process Development
Patentable Novel Process Development
Process Improvement Projects (Cost Reduction Projects)
Dossier Preparation & Technology Transfer
Analytical Services: Raw Material Characterization as per
latest Pharmacopoeia (USP / BP / EP / IP / JP)
Method Development as per ICH Guidelines
Method Validation as per ICH Guidelines
Impurity Profiling: Method development, Identification, Isolation, Characterization
Qualification of Standards: Preparation, Characterization & Establishing Mass by Assay (Potency Determination)
Organic Volatile Impurities, Residual Solvents as per USP / EP
CHEMISTRY SERVICES
BIONEEDS SERVICES / CAPABILITIES
INSTRUMENTATION
LC-MS/MS & LC-MS-TOF
HPLC
GC-Head Space
UV
FTIR
PCR
TOC
1D / 2D Gel Electrophoresis
SpectraMax M5e
Randox Clinical Chemistry Analyzer
ADVIA 120 & 2120 Hematology System
Physicochemical
Analytical Chemistry
Five Batch Analysis (Impurity
Profile)
Toxicology
Ecotoxicology
Genetic Toxicology
Six Pack Studies
Bioassay for Biopesticides
REACH Services
AGROCHEMICALS / INDUSTRIAL CHEMICALS
MEDICAL DEVICES
In vitro Skin Irritation & Ocular
Irritation Studies
In vitro Dermal Percutaneous
Absorption Studies
Local Lymph Node Assay – LLNA
(BrdU - ELISA Method)
Direct Peptide Reactivity Assay
(DPRA)
In vitro 3T3 NRU Phototoxicity Test
Bovine Corneal Opacity &
Permeability Test (BCOP)
BIOLOGICS / BIOSIMILARS /BIOPHARMACEUTICALS
Custom Assay Development Services
Stability Services
Biologics / Biosimilars / Biopharma
CMC Support Assays
Bioanalytical Services (PK / TK /
Immunogenicity / In vitro Assays)
Final Product Characterization
Antibody Production, Purification,
Labeling & Characterization
Host Cell Contamination
Efficacy
Toxicology
RCGMSchedule YEMEAFDA
ALTERNATIVES TO ANIMALSTUDIES
OECDCIBRC/KCREPAOPPTSCIPAC
Cytotoxicity
Skin Sensitization
Irritation / Intracutaneous Reactivity
Systemic Toxicity
Genotoxicity
Implantation Studies
Hemocompatibility Test
Toxicokinetics
Immunotoxicity
Physicochemical Studies
USPIPBPEPSP
ISO10993ASTMAMMT
Email: [email protected]
PRECLINICAL SERVICES
BIOLOGICAL TESTS
Biological Activity / Potency (In vitro / In vivo / Ex vivo)
Quantification (Colorimetric / UV 280) Process Related Contaminants /
Impurity Carry Over Determination Endotoxin (Qualitative & Quantitative) Host Cell DNA & Host Cell Protein pH (Liquid samples) SDS PAGE Sterility, Identity, Purity, Copy Number /
Gene Integration Mycoplasma Detection / Quantification Antibody Production, Purification,
Labeling & Characterization Biologic / Bio-similar / Biopharma CMC
Support Assays Final Product Characterization Bioanalytical Services (PK / TK /
Immunogenicity / In vitro Assays for Biologics / Biosimilars & Biopharma Products)
Stability Services Clinical Trial Sample Analysis
ECOTOXICITY
Alga, Growth Inhibition Test (Pseudokirchneriella Subcapitata)
Lemna, Growth Inhibition Test (Lemna gibba & Lemna minor)
Acute Immobilisation & Reproduction Test (Daphnia magna)
Fish, Acute Toxicity Test (Common Carp, Rainbow Trout, Guppy etc.)
Honeybees, Acute Oral & Contact Toxicity Tests (Apis mellifera, Apis indica)
Earthworm, Acute & Reproduction Toxicity Tests (Eisenia fetida fetida)
Avian Dietary Toxicity Test (Coturnix coturnix japonica)
Avian Acute Oral Toxicity Test (Coturnix coturnix japonica)
Avian Reproduction Test (Coturnix coturnix japonica)
Silk Worm Toxicity Test
Prenatal Developmental Toxicity
One / Two Generation Reproduction Toxicity
Combined Reproduction / Developmental Toxicity
Seg I, II & III Studies
Developmental Neurotoxicity
Hershberger Bioassay
Uterotrophic Bioassay
REPRODUCTION & DEVELOPMENTAL TOXICITY
SUBCHRONIC & CHRONICTOXICITY
90 / 180 Days Repeated Dose Carcinogenicity Chronic Toxicity Studies / Combined
Chronic & Carcinogenicity Studies Neurotoxicity Studies Repeated Dose Infusion Studies Juvenile Toxicity Delayed Neurotoxicity Studies in
Chicken
Color Physical State Odour Flash Point Storage
Stability Miscibility Corrosion Test Density Viscosity Melting Point Boiling Point Flammability Self Ignition Auto Ignition
pH Partition Co-efficient Particle Size Hydrolysis Dissociation
Constant Thermal Stability Surface Tension Absorption &
Desorption Solubility Emulsion Stability Vapor Pressure Explosive Properties Oxidizing properties
PHYSICAL CHEMISTRY
ROUTES OF ADMINISTRATION
Oral Inhalation Intravenous Ocular Dermal Intradermal Intramuscular Intranasal
Intratracheal Subcutaneous Intraocular Intracorneal Infusion Intravitreal Intraperitoneal
IMMUNOTOXICOLOGY
Local Lymph Node Assay Immuno Histochemistry Vaccine Potency Test Closed Patch Test
Acute Oral / Dermal / IV / IM / SC / IP Acute Inhalation Acute Irritation / Corrosion Acute Eye Irritation / Corrosion Acute Infusion Studies Skin Sensitization by GPMT
ACUTE TOXICITY
Bacterial Reverse Mutation Test (AMES) In vitro Chromosome Aberration Test In vivo Bone Marrow Chromosome
Aberration Test In vitro Mammalian Cell Micronucleus
Test Mammalian Gene Mutation Test (HPRT /
Mouse Lymphoma) Mammalian Erythrocyte Micronucleus
Test
GENETIC TOXICITY
SUB ACUTE TOXICITY
7/14 Days Dose Range Finding Study 14 / 28 Days Repeated Dose Studies
ENDOCRINE SCREENING
Hershberger Bioassay Uterotrophic Bioassay
INHALATION TOXICOLOGY SERVICES
Bioneeds offers Inhalation toxicology services to the pharmaceutical, agrochemical, chemical
& consumer products industries. The facility is designed to provide GLP studies in
accordance with testing guidelines of the FDA, EPA, OECD & other regulatory agencies.
INHALATION TOXICITY STUDIES IN RODENTS:
Acute inhalation study for agrochemicals / industrial chemicals (EC B.2., OECD 403,
OPPTS 870.1300, CIBRC)
Acute inhalation study for pharmaceuticals
Repeated dose (28 / 90 days) inhalation studies for agro chemicals (OECD 412, OECD 413)
Repeated dose (28 / 90 days) inhalation studies for pharmaceuticals (Schedule Y)
Bioneeds is the partner of choice for high quality, scientifically driven & economical single &
repeated dose inhalation studies
E-FATE & RESIDUE
Residue & Persistence Direct Photolysis Hydrolysis Carbon / Nitrogen Transformation Biodegradability
www.bioneeds.in
BIOANALYTICAL
Antibody Production, Purification, Labelling & Characterization
Biologics / Biosimilars / Biopharma CMC Support Assays
Final Product Characterization Bioanalytical Services (PK / TK /
Immunogenicity / In vitro Assays for Biologics / Biosimilars & Biopharma Products)
Custom Assay Development Services
Stability Services Clinical Trial Sample Analysis Host Cell Protein Analysis
MOLECULAR BIOLOGY
Bacterial, Yeast & Mammalian System
Protein Production & Purification QPCR / RT PCR
CELL CULTURE
Mycoplasma Testing Hybridoma Development Hepatocyte Isolation Neutralizing Antibody Assays Monoclonal Antibody Production Cell Proliferation Assays
MICROBIOLOGY
Total Microbial Count Pathogen Detection Preservative Efficacy Testing In vitro Antimicrobial Test In vitro MIC Screening Anti-dandruff Assays Anti-acne Assay
Infectious Models Murine Systemic Infection Model
Murine Thigh Infection Model
Murine Skin Infection Model
Keratitis Rabbit Model
ANALYTICAL
Determination of Physicochemical Properties
Determination of Active Ingredient Content (Purity)
Five Batch Analysis (Impurity Profile) Storage Stability Studies Analytical Services to Support
Toxicological Studies (e.g., Dose Concentration, Homogeneity, Stability Determination)
HISTOPATHOLOGY
Gross Pathology Organ Collection & Preservation Tissue Processing Embedding Sectioning Slide Preparation & Evaluation Histomorphometry Immunohistochemistry
CLINICAL PATHOLOGY
Hematological Parameters (Whole Blood)
Clinical Chemistry Parameters (Serum, Plasma & Body Fluids)
Urine Analysis
CATEGORIES
Drugs Specified in Schedule C & C(1)
Drugs other then those specified in Schedule C / C(1) (excluding Homeopathic Drugs)
Cosmetics
PHYSICOCHEMICAL TESTING
Identification by Chemical & UV Spectrophotometer
Determination of pH.
Moisture Content Analysis (LOD)
Disintegration & Dissolution
Analytical Method Development & Validation
Microbiology Culture Preparation & Identifications
Stability Studies (Real Time & Accelerated Stability Studies)
Color measurements & Identifications
Bulk density & Tap Density
Viscosity Measurements
Ash Value Determination
Weight Variation
Sieve Analysis
Related Substances
Content Uniformity
Refractive Index
Impurity Profile
Particle Size Evaluation
Assay
Distillation
Thickness
Limit Tests
Titrations
Melting point
Friability
Hardness
LABORATORIES
QUALITY ASSURANCE
Quality Assurance Unit (QAU) at Bioneeds ensures compliance with GLP. QAU inspections
ensure the studies that are performed are as per study plans designed in compliance with
the required guidelines. The Standard Operating Procedures are reviewed by the QAU to
ensure that the guideline requirements & GLP requirements are met. The QAU is actively
involved in reviewing the study plans, conducting in-life phase inspections & report findings.
Regular in-house training programs are conducted by the QAU for the staff to ensure
highest quality & compliance to OECD GLP standards.
Email: [email protected]
GALLERY
GLP Accredited Preclinical Development CenterDevarahosahally, Sompura Hobli, Nelamangala Tq, Bangalore Rural District-562111, Karnataka, INDIA
Tel: +91 816-2214400
Chemistry & Biopharma Facility P-3, Peenya Industrial Area, 1st Main Road, Peenya 1st Stage, Bangalore-560058, Karnataka, INDIA
Tel: +91 80-22658400
www.bioneeds.in | Email: [email protected] | Mobile No.: +91 98444 57677