Bioneeds India Pvt Ltd

Regulatory testing and Pharmacopoeial analysis is one of the most important process of the pharmaceutical Industry. Bioneeds provides regulatory compliant and quality drug analysis reports by testing various parameters of drugs in our drug testing lab.

Bioassays:
Menotropin FSH activity
BP | USP
• Test strain: Wistar / SD Rats
• 3 Doses as per Pharmacopoeia
• Paired ovaries Seminal vesicles weight determination
• Statistical tests and Potency calculation

Urofoliotropin (Residual LH)
BP | EP
• Test strain: Wistar / SD Rats
• 3 Doses as per Pharmacopoeia
• Ascorbic acid estimation
• Statistical tests and Potency calculation

Epoetin alfa (Eryrthopoietin)
EP
• Test strain: BALB/c mice
• 3 Doses as per Pharmacopoeia
• Reticulocyte count using Advia Analyzer
• Statistical tests and potency calculation

Other Biological Tests as per BP / EP / USP / JP / IP
• Abnormal Toxicity (Mice / Guinea pigs)
• Pyrogen tests (Rabbits)
• Test for Bacterial Endotoxins (commercial kits)
• Sterility tests
• Test for Microbial Contamination
• Microbiological Assay of Antibiotics
• Immunogenicity Tests (for HIV antigens, Hepatitis antigens etc)
• Tests for vaccines
• Efficacy of Antimicrobial Preservation
• Test for Histamine
• Blood and Blood related products

Physicochemical Tests
• Identification by Chemical and UV Spectrophotometer
• Determination of pH
• Moisture Content Analysis (LOD)
• Disintegration & Dissolution
• Analytical Method Development & Validation
• Microbiology Culture Preparation and 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

Chamber Type: Nose-only Directed-Flow Rodent Inhalation Exposure Unit
Pharmaceuticals
Agrochemicals (Pesticides, Insecticides, Herbicides etc.)

GLP Inhalation Studies
•Acute Inhalation Toxicity Study for Agrochemicals/ Industrial Chemicals (EC B.2., OECD 403, OPPTS 870.1300, CIBRC)
•Acute Inhalation Toxicity Study for Pharmaceuticals (Schedule Y)
•Repeated Dose (28/90 days) Inhalation Toxicity Studies for Agro Chemicals (OECD412, OECD 413)
•Repeated Dose (28/90 days) Inhalation Toxicity Studies for Pharmaceuticals (Schedule Y)

Liquid
•LC (Liquid Concentrate) , EC (Emulsifiable Concentrate) , SC (Suspension Concentrate) , Technical grade

Dust
•WG/WSG (Water Dispersible Granule),SG (Soluble Granule), WP ( Wettable powder), Technical Grade

• Ames test
• Chromosomal Aberration
• Micro-nucleus test
• Mouse Lymphoma

• LLNA
• Immunohistochemistry
• TDAR

• Caco-2 permeability
• Plasma protein binding
• Solubility
• Microsomal/S9 stability
• Blood / Plasma ratio
• CYP liabilities
• Pharmacokinetics / Toxicokinetics
• Tissue distribution

• hERG
• Telemetry
• FOB / Irwin test
• Respiratory assessment

• Dose limiting toxicology studies
• Dose escalation toxicology studies

• Single dose studies
• Repeated dose studies
• Chronic toxicology studies
• Developmental & Reproduction toxicology

• Prenatal Developmental Toxicity
• Reproduction/Developmental Toxicity Screening Test
• Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening
• Segment I, II & III Studies

• Generation of Hits
• Transforming Hits to Leads
• Optimization of Leads
• Developing drug candidates
• Biological screenings against known or client's targets

• Sensitive reactions from milligram to kilogram scale
• Reaction temperature ranging from -780C to 2500C
• Chiral Chemistry, Asymmetric synthesis & chiral resolution
• Halogenation, Nitration, Sulfonation, Cyanation
• LDA, n-BuLi, t-BuLi, NaH, NaNH reactions
• NaBH4 , LiAlH4 , Borane, DIBAL, Pd/C, Pt2O reactions
• Suzuki, Buchwald, Mitsunobu, Friedel-Crafts, Wittig, Grignard reactions

• 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, Isolation and Characterization
• Trace / heavy metal analysis using AAS and ICP-MS techniques
• Organic Volatile Impurities, Residuals, solvents as per USP
• Extractable and Leachables analysis

• Route scouting
• Process optimization
• Impurity profiling
• Identification of Critical Process Parameters Using Design of Experiment (DoE)
• Analytical Method Development
• Process Development for ready commercialization
• Manufacturing from gram to multi kilograms level

Chemistry:
We undertake custom synthesis from milligram to kilogram scale, process development / optimization, development of cost reduction processes, novel and non-infringing processes.

GLP Toxicology Studies
• Acute Toxicity Studies – Oral & Dermal
• Corrosion, Irritation & Skin sensitization
• Acute & Repeated dose Inhalation studies
• Repeat-dose Sub-acute, Sub-chronic and Chronic studies
• Reproductive Toxicity studies
• Geno-toxicity studies

Mammalian Toxicology:
• Single dose studies
• Repeated dose studies
• Chronic toxicology studies
• Developmental & Reproduction toxicology

Eco-toxicology Studies
Ecotox studies will be conducted as per CIBRC, OECD, EC, EPA OCSPP, ISO, JMAFF, SETAC and other regulatory Test Guidelines on wide range of test species:
• Alga
• Lemna
• Daphnia
• Fish
• Earthworm
• Birds
• Honeybees

Phys-Chem Studies
• 5-batch analysis
• Analytical testing & Characterization as per OECD
• Impurity profiling
• Synthesis of Impurities, Metabolites and Intermediates

Other Studies
• E-fate studies
• Biodegradability studies

Bioneeds routinely evaluates Biological safety for varied types of Medical Devices as per ISO 10993. Data generated at Bioneeds has been well accepted by USFDA (for 510K & PMA), EU (for CE Marking) and other regulatory agencies. Our clientele includes national and international companies viz. UK, France, US, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan & ROW.

Cytotoxicity Tests
• Agar Overlay
• MEM Elution
• MTT Assay / XTT Assay
• Neutral Red Uptake
• Colony Formation

Systemic Toxicity Tests
• Acute
• Sub-acute
• Sub-chronic
• Chronic

Implant Tests
• Intramuscular
• Subcutaneous
• Bone
• Relevant Clinical Site (Ex: Intraperitoneal, Bone / Joint, Dental, Spine, Ocular and Calvarial)

Genotoxicity Tests
• Bacterial Mutation (AMES) Test
• Mouse Iymphoma
• In vitro & In vivo micronucleus
• In vitro & In vivo chromosomal aberration

Irritation Tests
• Primary Skin Irritation
• Intracutaneous Reactivity
• Ocular Irritation
• Mucosal Irritation (Oral, Rectal, Vaginal & Penile)

Hemocompatibility Tests
• Hemolysis Test
• Prothrombin Time (PT)
• Partial Thromboplastin Time (PTT / Inactive PTT)
• Complement Activation (C3a & SC5b-9)
• Platelet Aggregation / Activation
• Coagulation
• Thrombosis / Fibrinolysis
• Leukocyte Activation

Plastics Testing
Biocompatibility Tests for Classifications of Plastics (USP Class VI Test)

Medical Device Toxicity Risk Assessment

Sensitization Tests
• Buehler Sensitization Method
• Maximization (Magnus-Kligman)
• Local lymph Node Assay (LLNA)

Pyrogenicity Tests
• In vitro Bacterial Endotoxins
• Material Mediated Rabbit Pyrogen Test

Others
• Carcinogenicity
• Reproductive Toxicity
• Teratogenicity
• Immunotoxicity / Immunogenicity

Regulatory Guidelines
• ISO 10993
• ASTM
• US FDA
• AAMI
• Product Specific ISO Guidelines
• Pharmacopoeia (USP / BP / IP)

Alternate To Animal Studies

• Bovine Corneal Opacity and Permeability Test (BCOP)
• Direct Peptide Reactivity Assay (DPRA)
• In Vitro Skin Irritation Test (EpiskinTM / EpidermTM)
• In Vitro Dermal absorption (EpiskinTM / EpidermTM)
• In Vitro 3T3 NRU Phototoxicity
• Local Lymph Node Assay (LLNA): BrdU-ELISA

Bioneeds serves the cosmetic industry considering the new legislation requirements with the In vitro alternatives to the animal studies. We offer alternate testing services to formulators and manufacturers of cosmetic and other personal care products.

• Alternatives To Animal Studies
• In Vitro Dermal absorption (EpiskinTM / EpidermTM) / Human Cadaver Skin / Porcine skin
• Bovine Corneal Opacity and Permeability Test (BCOP)
• Direct Peptide Reactivity Assay (DPRA)
• LAL test
• In Vitro Ocular Irritation Test (EpiOcularTM)
• In Vitro 3T3 NRU Phototoxicity
• Cytotoxicity

• Oral • Sublingual • Inhalation • Intravenous • Ocular • Dermal • Intra dermal • Intramuscular • Intratracheal • Subcutaneous • Intraocular • Intracorneal • Infusion

• Formulation method development & validation • Bio-analytical method development & validation

Bioneeds can offer Custom Synthesis of a wide variety of organic compounds on the milligram to kilogram scale at a competitive price.
• New Chemical Entities (NCE's)
• Heterocyclic building blocks & Scaffolds
• Complex molecules, Intermediates and Prodrugs
• Reference compounds synthesis
• Metabolites & Impurities synthesis

Bioneeds is dedicated to provide end-to-end Biologics Drug Development Services with its two distinct technology platforms:
• Preclinical Platform
• Drug Development Platform

Capabilities include development of recombinant proteins such as non-glycosylated proteins; glycoproteins and monoclonal antibodies derived from either bacterial or mammalian host expression systems.
Our Preclinical platform is supported by OECD-GLP and AAALAC certified animal facilities.
We have the expertise to handle Novel Biologics, Biosimilars and Biobetters.

CQA Driven Process & Product Development
• Cell Line Development
• Cell Banking & Characterization
• Upstream Process Development
• Downstream Process Development
• Formulation & Stability

Well Characterized Products
• Structure
• Function (MOA)
• Safety
• Toxicology
• Immunogenicity

Preclinical Studies:
• Animal Toxicity
• PK / PD
• Immunogenicity
• POC studies MOA

Biopharmaceuticals
• Pre-clinical Toxicology (GLP / Non GLP)
RCGM; EMEA; US-FDA
• Bioassays (In vitro / In vivo): (GLP / Non GLP)
Method Development; Validation;
Sample Analysis
• PK/TK Analysis (GLP / Non GLP)
Animal Studies; Sample Analysis
• Immunogenicity Testing (GLP / Non GLP)
Antibody Generation; Screening Assays; Confirmatory Assays; Neutralizing Antibody Assays
• Impurity Analysis (GLP / Non GLP)
HCP; HCD; Others
• Antibody Development (Monoclonal / Polyclonal)
Immunization; Purification; Characterization; Reactivity

Drug Development Platform
• Cell Line Development
Codon Optimization; Clone Stability; Bioreactor Suitability; Titre ; Product Quality
• Process Development
Cell Culture & Purification ; Critical Process Parameters; COGS
• Product Characterization
Analytical; Bio / Analytical; Potency (Compliance to Standard Guidelines and Pharmacopeia)
• Product Release Testing
Compliance to Standard Guidelines and Pharmacopeia
• Sequence to Clinic (Pre-IND Package)
Complete Product Development (starting with sequence) with tox material supply

Regulatory testing and Pharmacopoeial analysis is one of the most important process of the pharmaceutical Industry. Bioneeds provides regulatory compliant and quality drug analysis reports by testing various parameters of drugs in our drug testing lab.

Bioassays:
Menotropin FSH activity
BP | USP
• Test strain: Wistar / SD Rats
• 3 Doses as per Pharmacopoeia
• Paired ovaries Seminal vesicles weight determination
• Statistical tests and Potency calculation

Urofoliotropin (Residual LH)
BP | EP
• Test strain: Wistar / SD Rats
• 3 Doses as per Pharmacopoeia
• Ascorbic acid estimation
• Statistical tests and Potency calculation

Epoetin alfa (Eryrthopoietin)
EP
• Test strain: BALB/c mice
• 3 Doses as per Pharmacopoeia
• Reticulocyte count using Advia Analyzer
• Statistical tests and potency calculation

Other Biological Tests as per BP / EP / USP / JP / IP
• Abnormal Toxicity (Mice / Guinea pigs)
• Pyrogen tests (Rabbits)
• Test for Bacterial Endotoxins (commercial kits)
• Sterility tests
• Test for Microbial Contamination
• Microbiological Assay of Antibiotics
• Immunogenicity Tests (for HIV antigens, Hepatitis antigens etc)
• Tests for vaccines
• Efficacy of Antimicrobial Preservation
• Test for Histamine
• Blood and Blood related products

Physicochemical Tests
• Identification by Chemical and UV Spectrophotometer
• Determination of pH
• Moisture Content Analysis (LOD)
• Disintegration & Dissolution
• Analytical Method Development & Validation
• Microbiology Culture Preparation and 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

Nutraceuticals are products derived from the food sources with extra health benefits in addition to the basic nutritional value found in foods. It is a fast growing sector and worldwide regulatory authorities are focusing on the safety and quality of the nutraceutical products as these are meant for human consumption. Bioneeds offers wide range of safety and physicochemical analysis for nutraceutical products.

Herbal medicines have been in the forefront of research for therapies in various areas. There are several guidelines published to support the application of evaluation principles by modern science to a tradition of herbal medicine that is extremely vibrant and of growing interest throughout the world.
Bioneeds provides GLP Acute studies, long term studies, local toxicity studies and special toxicity studies in addition to Physico chemical & analytical studies required for evaluation of herbal medicines.

Specializations in Herbals / Nutraceuticals
Nutritional labelling – US FDA labelling requirements: Trace analysis, Pesticide residues, Drug residues, Antibiotic residues, DIOXINS, Toxic metals, Aflatoxins.
Nutritional facts, Amino acids profile, Water soluble vitamins by HPLC–B1, B2, B3, B6 and C, Fat soluble vitamins A, D etc., by HPLC

Microbiology Analysis of Herbal, Nutraceuticals and Drug Compounds
• Total viable Bacterial count
• Combined Yeast mould
• Pathogen analysis like Salmonella, E.coli, Streptococci etc.
• Biochemical confirmatory tests of pathogens
• Swab testing

Bioanalytical Assays Services

Formulation Services

Biology Services

Cells and Tissues Services

Cell and Tissue Culture Services

Mammalian Cell Culture Services

Microbiology Services

Manufacturing Services