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: bioneeds@bioneeds.in

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: bioneeds@bioneeds.in

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: bioneeds@bioneeds.in | Mobile No.: +91 98444 57677