BIONEEDS


Agrochemicals


Pharmaceuticals


Biopharmaceuticals Medical
Devices


Nutraceuticals
/

Herbals

 Veterinary
Drugs


Cosmetics
/
Topical
Drugs
Drug
Testing
(Alternatives
to

Animal
Studies)


 Internationally
acclaimed
Contract
Research
Organization



 World
class
infrastructure
with
cutting
edge
technology
 Conformance
to
global
regulatory
norms
(USFDA,
EPA,
OECD,
EEC,
MAFF,

EMEA,
MHRA,
ANVISA,
DCGI,
CIBRC,
RCGM)
 Best
in
industry
team
leads
and
talent
pool
with
extensive
industry

experience
and
domain
expertise

 Outstanding
customer
services
and
commitment
to
scientific
excellence
and

quality
through
best
in
class
services
 BIONEEDS
INDIA
PRIVATE
LIMITED
is
a
Bangalore
based
Contract
Research
Organization,

providing
Integrated
Discovery,
Development
&
Regulatory
Services
to
Pharmaceutical,

ABOUT
US Biopharmaceutical,
Agrochemical,
Industrial
chemical,
Herbal
/
Nutraceutical
&
Medical
device

companies.

STATE­OF­THE­ART
FACILITIES

 Best­in­class
infrastructure
in
a
2,50,000
sq.ft.
built­up
area
equipped

with
state­of­the­art
facilities
 Vivarium
with
85
exclusive
animal
rooms
built
as
per
international

standards
 Cutting
edge
drug
discovery
&
development
labs
to
support
biology,



In
vivo
pharmacology,
pharmacokinetics,
toxicology,
medicinal

chemistry,
custom
synthesis,
process
R&D,
cGMP
manufacturing,

formulation
&
analytical
development
services

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.
 
 tate
Drug
Controller
as
a
Government
approved
Drug
Testing
Laboratory
for
carrying
out
tests
on
Drugs
/
Cosmetics
and
Raw

S
Materials
used
in
manufacture
on
behalf
of
licensees
for
manufacture
and
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)
 R&D
unit
recognized
by
Department
of
Scientific
&
Industrial
Research
(DSIR)
 US
FDA
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


AGROCHEMICALS
/
BIOLOGICS
/
 INDUSTRIAL

BIOSIMILARS
/ CHEMICALS
MEDICAL
DEVICES

BIOPHARMACEUTICALS
/
VACCINES


PHARMACEUTICALS
/

HERBALS
/
BIONEEDS
 COSMETICS
/

TOPICAL
DRUGS
NUTRACEUTICALS
/
 INTEGRATED
DISCOVERY, (ALTERNATIVES
TO

VETERINARY
DRUGS

 ANIMAL
STUDIES)

DEVELOPMENT
AND

REGULATORY
SERVICES


Telephone:
+91
816­2214400


|


Mobile
no.:
+91
98444
57677



 BIONEEDS
SERVICES
/
CAPABILITIES


PHARMACEUTICALS
/
HERBALS
/ AGROCHEMICALS
/
 CHEMISTRY
SERVICES

NUTRACEUTICALS
 INDUSTRIAL
CHEMICALS
Medicinal
Chemistry:
 ADME
PK
/
In
vivo
&
In
vitro  Physicochemical
  Generation
of
Hits
&
Transforming

 Proof
of
Concept  Analytical
Chemistry Hits
into
Leads
 Lead
optimization
&
Support
for
Drug

 Efficacy
 ICH  Five
Batch
Analysis
(Impurity

 Toxicology Schedule
Y Profile)
 Candidate
Nomination

OECD  Library
Synthesis

 Physicochemical

  Toxicology OECD
FDA CIBRC Custom
Synthesis:























 Batch
Release
Testing


  Ecotoxicology EPA (From
mg
to
multi
kg
scale)
 Genetic
Toxicology OPPTS  New
Chemical
Entities
(NCEs)
 Six
Pack
Toxicity
Studies CIPAC
 Heterocyclic
Building
Blocks
&


IMPURITY
QUALIFICATION  Bioassay
for
Biopesticides Scaffolds

 REACH
Services
  Complex
Molecules
&
Prodrugs
Numerous
Studies
Conducted
&
  Key
Raw
Materials,
Advanced

Successfully
Submitted
to
Different

MEDICAL
DEVICES
 Intermediates
etc.
Regulatory
Agencies  Impurities
&
Stable
Metabolites
–

BIOASSAYS
 
 Menotropin
­
FSH
/
LH
Activity
 Human
Chorionic
Gonadotropin
 Estrogenic
Activity
 Follitropin,
Residual
LH
Activity
 Erythropoietin
(EPO)
 Biological
Risk
Assessment  Support
in
Identification
&

 Biocompatibility Characterization

Cytotoxicity  Preparation
/
Isolation,
Qualification

 Skin
Sensitization
 &
Supply
 Irritation
/
Intracutaneous
Reactivity  Working
/
Reference
Standard
–

 Systemic
Toxicity Preparation,
Qualification
&
Supply
 Genotoxicity ISO10993  Library
Synthesis

Implantation
Studies
 ASTM

US
FDA Drug
Development:
 Hemocompatibility
Test  Process
Development
&
Optimization


 Insulin
Assays USP of
NCEs


IP  Forms
Selection
 Rabbit
Pyrogen
Testing BP ALTERNATIVES
TO
ANIMAL  Material
Generation
as
Required
for

Endotoxin
Testing EP

JP
STUDIES
FOR
TESTING
COSMETICS,
 Pre­clinical
(non­clinical)
Studies

 Abnormal
Toxicity TOPICAL
DRUGS
&
CHEMICAL
  Phys­Chem
Studies

SUBSTANCES



  Method
Development
&
Validation
 Sterility
Tests
 Qualification
of
Standards
 Test
for
Microbial
Contamination  In
vitro
Skin
Irritation
&
Ocular

 Forced
Degradation
 Microbiological
Assay
of
Antibiotics Irritation
Studies

 Stability
Studies
 Immunogenicity
Tests
(for
HIV
  In
vitro
Dermal
Percutaneous

Process
Research:

Absorption
Studies
/
IVPT

Antigens,
Hepatitis
Antigens
etc)  Expertise
in
Quality
Process

 Local
Lymph
Node
Assay
–
LLNA

 Efficacy
of
Antimicrobial
Preservation Research
for
APIs
(Active
Pharma

(BrdU
­
ELISA
Method) Ingredients)
&
AIs
(Active

 Test
for
Histamine Direct
Peptide
Reactivity
Assay


Ingredients)

 Specific
Activities (DPRA)  Route
Scouting,
Non­infringing


 In
vitro
3T3
NRU
Phototoxicity
Test Process
Development

 Bovine
Corneal
Opacity
&
  Patentable
Novel
Process


Permeability
Test
(BCOP) Development

BIOLOGICS
/
BIOSIMILARS
/  Process
Improvement
Projects
(Cost

BIOPHARMACEUTICALS  Isolated
Chicken
Eye
(ICE)
Test
Reduction
Projects)
 In
vitro
Skin
Corrosion
Test
 Dossier
Preparation
&
Technology

 Custom
Assay
Development
Services  In
vitro
Phototoxicity
Test
Transfer
 Biologics
/
Biosimilars
/
Biopharma


 Analytical
Services:
CMC
Support
Assays  Raw
Material
Characterization
as
per

VACCINES

 latest
Pharmacopoeia
(USP
/
BP
/
EP

 Bioanalytical
Services
(PK
/
TK
/

Potency
Testing
 /
IP
/
JP)
Immunogenicity
/
In
vitro
Assays) 
 Method
Development
&
Validation
as

 Immunogenicity
 Final
Product
Characterization per
ICH
Guidelines
 Toxicology
 Antibody
Production,
Purification,
  Impurity
Profiling:
Method

 Batch
Release
Test
IP,
BP development,
Identification,
Isolation,

Labeling
&
Characterization  Dose
Stability
EP,
USP Characterization
 Host
Cell
Contamination RCGM  Efficacy
Test JP,
OECD  Qualification
of
Standards:


 Efficacy
Schedule
Y  Endotoxins Schedule
Y Preparation,
Characterization
&

EMEA  Abnormal
Toxicity
 WHO
 Toxicology FDA Establishing
Mass
by
Assay
(Potency

 Sterility Determination)
 1D
/
2D
Gel
Electrophoresis
  Pyrogens  Organic
Volatile
Impurities,
Residual

 Physicochemical
 Solvents
as
per
USP
/
EP

Email:
bioneeds@bioneeds.in
 PRECLINICAL
SERVICES

ACUTE
TOXICITY
 IMMUNOTOXICOLOGY
 ECOTOXICITY


 Acute
Oral
/
Dermal
/
IV
/
IM
/
SC
/
IP
/
  Local
Lymph
Node
Assay Aquatic
Ecotoxicology
Ocular  Immuno
Histochemistry
 Acute
Inhalation
  Vaccine
Potency
Test  Freshwater
Alga
&
Cyanobacteria,

 Acute
Dermal
Irritation
/
Corrosion  Closed
Patch
Test
 Growth
Inhibition
Test
 Acute
Eye
Irritation
/
Corrosion
 Daphnia
Acute
Immobilization
Toxicity

Study
 Acute
Infusion
Studies
 BIOLOGICAL
TESTS  Daphnia
Magna
Reproduction
Test
 Skin
Sensitization
by
GPMT
 Biological
Activity
/
Potency
(In
vitro
/






  Acute
Fish
Toxicity
Study
In
vivo
/
Ex
vivo)  Fish,
Early­Life
Stage
Toxicity
Test
SUB
ACUTE
TOXICITY
  Quantification
(Colorimetric
/
UV
280)  Chironomous
Acute
Immobilization
Test
 Process
Related
Contaminants
/
  Microbial
Pesticide
Test
 7/14
Days
Dose
Range
Finding
Study Impurity
Carry
Over
Determination  Lemna
Toxicity
Study
 14
/
28
Days
Repeated
Dose
Studies  Endotoxin
(Qualitative
&
Quantitative)
 Host
Cell
DNA
&
Host
Cell
Protein  Water­Sediment
Myriophyllum

 pH
(Liquid
samples) Spicatum
Toxicity
Test
SUBCHRONIC
&
CHRONIC  SDS
PAGE
 Purity Terrestrial
Ecotoxicology
TOXICITY Mycoplasma
Detection
/
Quantification
  Acute
Oral
Toxicity
Study
In
Honeybees
 Antibody
Production,
Purification,

 90
Days
Repeated
Dose
Studies  Acute
Contact
Toxicity
Study
In

Labeling
&
Characterization
 180
Days
&
above
Chronic
Toxicity
  Biologic
/
Bio­similar
/
Biopharma
CMC
 Honeybees
Studies
/
Combined
Chronic
&
 Support
Assays
  Acute
Toxicity
Study
In
Earthworm
Carcinogenicity
Studies  Final
Product
Characterization  Earthworm
Reproduction
Test
 Carcinogenicity
Studies  Bioanalytical
Services
(PK
/
TK
/
  Avian
Acute
Oral
Toxicity
Study
 Neurotoxicity
Studies Immunogenicity
/
In
vitro

Assays
for

Biologics
/
Biosimilars
&
Biopharma
  Acute
Delayed
Neurotoxicity
Studies
 Repeated
Dose
Infusion
Studies Products)  Avian
Acute
Dietary
Toxicity
Study
 Juvenile
Toxicity  Neutralizing
Antibody
Assays  Silk
Worm
Acute
Toxicity
Test
 Monoclonal
Antibody
Production
 Cell
Proliferation
Assays  Trichogramma
Toxicity
Test
REPRODUCTION
&
  Terrestrial
Plant
Test:
Vegetative
Vigour

DEVELOPMENTAL
TOXICITY Test
PHYSICAL
CHEMISTRY
  Terrestrial
Plant
Test:
Seedling

 Prenatal
Developmental
Toxicity
 Color  pH Emergence
and
Seedling
Growth
Test
 1
/
2
Generation
Reproduction
Toxicity
 Physical
State  Partition
Co­efficient
  Laboratory
test
assessment
of
plant

 Combined
Reproduction
/
 Odour Particle
Size
  Protection
Products
in
non­
target

Developmental
Toxicity  Flash
Point  Hydrolysis arthropods
 Seg
I,
II
&
III
Studies  Storage
  Dissociation
Constant
Stability Thermal
Stability
 Collembolan
Reproduction
Test
 Developmental
Neurotoxicity 
 Miscibility
  Surface
Tension  Predatory
mite
(Hypoaspis
(Geolaelaps)

 Hershberger
Bioassay  Corrosion
Test  Absorption
&
 aculeifer)
reproduction
test
in
soil
 Uterotrophic
Bioassay  Density
 Desorption
 Extended
One­Generation
  Viscosity  Solubility

Reproductive
Toxicity
Study  Melting
Point  Emulsion
Stability E­FATE
&
RESIDUE

 Boiling
Point  Vapor
Pressure
 Flammability  Explosive
Properties  Residue
&
Persistence
 Self
Ignition  Oxidizing
properties  Direct
Photolysis
GENETIC
TOXICITY
  Auto
Ignition  Hydrolysis
 Carbon
/
Nitrogen
Transformation
 Bacterial
Reverse
Mutation
Test
(AMES)  Biodegradability
 In
vitro
Chromosome
Aberration
Test ROUTES
OF
ADMINISTRATION  Activated
Sludge
Respiration
Inhibition

 In
vivo
Bone
Marrow
Chromosome
 Test
Aberration
Test  Oral
  Intratracheal
  Aerobic
and
Anaerobic
Transformation

 In
vitro
Mammalian
Cell
Micronucleus
  Inhalation  Subcutaneous in
Soil
Test
  Intravenous  Intraocular
 Mammalian
Gene
Mutation
Test
(HPRT
/
  Ocular  Intracorneal
Mouse
Lymphoma)  Dermal  Infusion ENDOCRINE
SCREENING
 Mammalian
Erythrocyte
Micronucleus
  Intradermal  Intravitreal

Test  Intramuscular  Intraperitoneal
 Hershberger
Bioassay
 Comet
Assay
  Intranasal  Uterotrophic
Bioassay

INHALATION
TOXICOLOGY
SERVICES

Inhalation
toxicology
studies
are
performed

 Acute
study
for
agrochemicals
/
industrial
chemicals

for
pharmaceutical,
agrochemical,
chemical
 (EC
B.2.,
OECD
403,

OPPTS
870.1300,
CIBRC)
&
consumer
products
industries.
Facility
is

 Acute
study
for
pharmaceuticals
designed
to
provide
GLP
studies
in

 Repeated
dose
(28
/
90
days)
studies
for

accordance
with
testing
guidelines
of
the
 agrochemicals
(OECD
412,
OECD
413)

 Repeated
dose
(28
/
90
days)
studies
for

FDA,
EPA
&
other
regulatory
agencies.
pharmaceuticals
(Schedule
Y)

www.bioneeds.in
PRECLINICAL
SERVICES
ANALYTICAL

 Physicochemical
Properties

 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)
 Analytical
Method
Development
&
Validation
 Residue
Studies
 E­Fate
Studies

BIOANALYTICAL

 Bioanalytical
Services

(PK
/
TK
/
Immunogenicity
/
In
vitro

Assays
for
Biologics
/
Biosimilars
&
Biopharma
Products)
 Custom
Assay
Development
Services
 Clinical
Trial
Sample
Analysis
 Host
Cell
Protein
Analysis
(HCP)
 Host
Cell
DNA
(HCD)

MICROBIOLOGY

 Total
Microbial
Count
 Total
Yeast
and
Mould
Count
 Pathogen
Detection
 Preservative
Efficacy
Tests
 In
vitro
Antimicrobial
Test
 In
vitro
MIC
Screening
 Time
Kill
Assays
MOLECULAR
BIOLOGY
 CATEGORIES
 Bacterial,
Yeast
&
Mammalian
System
  Drugs
Specified
in
Schedule
C
&
C﴾1﴿
 Protein
Production
&
Purification  Drugs
other
than
those
specified
in

 QPCR
/
RT
PCR Schedule
C
/
C﴾1﴿
﴾Excluding

Homeopathic
Drugs﴿
 Cosmetics

REACH
SERVICES
Rich
Experience
in
handling
Active
Ingredients
and
Final
Products
Technical
Grade
(Herbicides,
Fungicides,
Insecticides,

Biocides
etc.,)
Formulated
Products
(WG/
SC/
NF/
EC/
SL
etc.,)
Combination
Insecticides
Biopesticides

EU
Registration
support
 Plant
Protection
Products
(EU
Regulation
1107/2009)

 Biocides
(Biocidal
Products
Regulation
528/2012)


 Industrial
Chemicals
(REACH
Regulation
1907/2006)

Services
offered:
Analytical
Methods,
Physico­chemical
Testing,
5­batch
Testing
and
Toxicological
Studies­
 Acute
6
pack
&
Repeated
Dose

 Genetic
Toxicity


 Pathogenicity
/
Infectivity


 Reproductive
Toxicity

 Alternate
to
Animal
Studies

 Endocrine
Disruptor
screening

 Ecotoxicology
Studies

 Environmental
Fate

 Residue
Analysis
&
Field
Studies

QUALITY
ASSURANCE
UNIT

Independent
Quality
Assurance
Unit
(QAU)
ensures
compliance
with
in­house
SOPs,

GLP
and
related
guidelines
conforming
to
respective
regulatory
specifications.
QAU

actively
reviews
/
audits
study
plans,
in­life
phases,
report
and
facility
/
process.
QAU

imparts
continuous
in­house
GLP
training
to
staff
to
ensure
highest
quality
adherence

and
compliance
to
OECD
GLP
principles.

Email:
bioneeds@bioneeds.in
Bioneeds
India
Private
Limited, Bioneeds
India
Private
Limited,
GLP
Accredited
Preclinical
Development
Center
 Chemistry
&
Biopharma
Facility
Devarahosahally,
Sompura
Hobli,
 P­3,
Peenya
Industrial
Area,
1st
Main
Road,

Nelamangala
Tq,
Bangalore
Rural
District­562111,
 Peenya
1st
Stage,
Bangalore­560058,

Karnataka,
INDIA Karnataka,
INDIA
Tel:
+91
816­2214400 Tel:
+91
80­22658400

bioneeds@bioneeds.in www.bioneeds.in +91
9844457677