Integrated Discovery, Development &

Regulatory Services

Agrochemicals

Chemistry Services

Pharmaceuticals

Medical Devices

Biopharmaceuticals

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GLP Certified Preclinical Facility spread across 5 acre campus in the serene location at outskirts ofBangalore with 200,000+ Sq.ft built-up area.

85 plus State-of-the-Art animal testing units

50,000 Sq.ft chemistry and discovery facilities in Bangalore

10+ years of comprehensive services for Pharma, Medical device & Agrochemical to facilitateglobal registration requirements

~270 Employees;80% M.Sc; M.Pharm; M.VSc; 13% PhD, 1 DABT, 2 Veterinary pathologists; 50 plusexperienced study directors

Cater to Pharmaceutical, Biopharmaceutical, Nutraceutical, Agrochemical, Veterinary, Cosmeticand Medical device industry

About Us

Accreditations & Certifications

Successfully audited by USFDA(January 2017)

Drug Testing License (DTL) fortests on Drugs /Cosmetics & Raw Materials used in manufacturing for marketing permission

ISO 17025 Accreditation (NABL) for Biological, Chemical & Medical device Testing

AAALAC(Association for Assessment & Accreditation of Laboratory Animal Care International) accredited laboratory for animal care

Recognized by Department of Scientific and Industrial Research (DSIR) for in-house & Collaborative R&D

OECD GLP Certificate by National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India

Ministry of Environment, Forests and ClimateChange, GOI –Permission to conduct research in animals

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Animal Ethics

• CPCSEA registered and AAALAC accredited facility with approvals for animal use

• IAEC (Institutional Animal Ethics Committee ) approved protocols

• IBSC(Institutional Bio Safety Committee) for all recombinant product testing

Global EHS policies

• Aligned to Global requirements

• Compliance with all key regulatory guidelines

• Operational controls proportional to associated risks

• Statutory approvals available for Air & Water pollution, hazardous waste, electronic waste, biomedical waste

Stringent confidentiality

practices

• Mandatory CDA for all employees to ensure continued obligation on confidentiality / non disclosures

• Well established systems for protection of information at all levels

• IP assigned to client at the beginning of relationship

About us - Policies

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About us: Global Footprint

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400 plus clientele 6500 plus studies Experience of working with academic institution to big Pharma companies Studies submitted to almost all the global regulatory bodies

Technical Leadership

Dr. Nitin M. ShettyChief Technical Officer - Preclinical

Services

• Brings 30 Years of Pharma industry experience in drug discovery & development , senior leadership positions in Ranbaxy, and other leading CROs.

• PhD in Safety assessment , Mumbai University has specialized in Safety assessment , Pharmacokinetics & drug disposition

• A senior member of Preclinical services played a pivotal role in setting up Multi-vertical Preclinical Service operations.

• Led preclinical and clinical development of several types of NCEs, Biotech products , generics, medical devices and others.

Dr. Raghunath Reddy Chief Operations Officer - Preclinical

• Brings 20 years of GLP experience & having played a pivotal role in setting up Pre-clinical operations of Bioneeds.

• Obtained his PhD from KuvempuUniversity and has several acclaimed National & International publications.

• Has held technical leadership positions with Ranbaxy & Rallis

• With in depth knowledge of Global Regulatory requirements has standardized many new toxicity studies for global regulatory submissions.

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Dr. Vadiraj S GopinathChief Operations Officer –

Chemistry

• Brings more than 23 years of knowledge and understanding of drug discovery, development, process chemistry and technology transfer for commercialization.

• With PhD from the Mysore University , has several National & International publications and patents. Post-doc from University of California, San Francisco, USA.

• Prior to joining Bioneeds he has held technical leadership positions with GSK, Rallis India - A TATA Enterprise and CROs

Services for Pharma

• Exploratory studies – DMPK

• Efficacy models – Proof of Concept studies

• DRF, Mutagenicity- Discovery toxicity studies

• IND / NDA enabling Toxicity studies

• Impurity Qualification studies

• Bridging studies

• Safety Pharmacology* (with partner CRO)

• Bio-analytical Services

• Analytical services

*Bioneeds safety pharma facility under expansion

GUIDELINES

• ICH• OECD• EMEA-CHMP• US-FDA• SCHEDULE Y

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Services for Biopharma

• Pre-clinical Toxicology

• Bioassays (in vitro/ in vivo)

• PK/TK Analysis

• Immunogenicity Testing

• Screening ELISA

• Confirmatory ELISA

• NAb Assay

• HCP(Host cell protein)

• Product specific PAb generation

• Cascade Immunization

• HCP coverage through 2D gel Electrophoresis

• Highly sensitive ELISA method development , validation and transfer

• HCD(Host cell DNA)

• qPCR based method

• Antibody Development(PAb)

• Product Characterization-

HPLC (ProA, RP, SE,CE), LC-MS(ORBITRAP)-Intact mass, subunit analysis, peptide mapping, Cell/ELISA based assays, BIACORE based assays

• Product Release Testing-IP, EP/BP, JP, USP compliant methods

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DMPK, Safety and Efficacy screening

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In vivo efficacy models

• Oncology

• Inflammation and Hypersensitivity

• Metabolic disorders

• Renal Disorders

• Pain & Central Nervous System Disorders

• Osteoarthritis and other disease models

Discovery toxicology screening

• Mutagenicity screening – Mini Ames and Discovery Chromosomal aberration study

• 4,7,14 Day toxicity screening

• Mini hERG

• Fast track PK

Solution Properties Drug Absorption &

Transport In Vitro

Drug Metabolism In Vivo PK

Buffer Solubility PAMPA Metabolic Stability(Microsome, S9 & Hepatocytes)

Bioavailability(Rat , Mouse & Dog)

cLog P/Log D Caco-2 Permeation & Efflux

Metabolite Profiling (Microsome, S9 & Hepatocytes)

Plasma- Brain/Tissue Ratio(Rat & Mouse)

Chemical Stability CYP 450 Inhibition(Standard IC50, TDI & IC50 Shift)

Serial CSF(Rat)

Plasma Protein Binding CYP 450 Phenotyping Serial Bleed PK (Mouse)

Blood Partitioning P-gp Efflux

Toxicity Studies

Acute Toxicity Studies

• Acute oral/dermal and Inhalation toxicity study

• Skin and eye irritation study

• Eye irritation study

• Skin sensitization study

• MTD studies in rodents and non-rodents

Sub-chronic & Chronic Toxicity

• DRF in rodents and non-rodents

• 28/90/180 Days Repeated Dose Toxicity

• Carcinogenicity /chronic Toxicity Studies

/Combined Chronic/Neurotoxicity Studies

• Juvenile Toxicity

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Test System-Species

Rats-Wistar, Sprague Dawley; Mice-Swiss albino, Balb/C, C-57, CBA/J ;Rabbits-New Zealand White; Guinea pigs-Dunkin Hartley; Dogs-Beagle Dogs

Toxicity Studies

Genotoxicity Studies

• Bacterial Reverse Mutation Test (AMES)

• In vitro Mammalian Chromosome Aberration Test(CHO and HPBL cells)

• In vivo Mammalian Chromosome Aberration Test

• In vitro Mammalian Cell Micronucleus Test• In vivo Mammalian Cell Micronucleus Test

• In vitro Mouse Lymphoma Assay

• Comet Assay

Reproduction & Developmental Toxicity

• Prenatal Developmental Toxicity

• Reproduction/Developmental Toxicity Screening Test

• Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening

• Segment I, II & III Studies

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Inhalation Toxicology and other routes of administration

Chamber Type: Nose-only Directed-Flow Rodent Inhalation Exposure Unit –

Pharmaceuticals

GLP Inhalation Studies

• Acute Inhalation ToxicityStudy for Pharmaceuticals(Schedule Y)

• 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

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Routes of Administration(ROA): Oral (Dietary / Gavage), SC, IM, IV, IP, Inhalation, Infusion, Ocular, Intra-vitreal, Dermal,Tropical

Alternative to Animal Studies

Alternate Studies Animal Studies

• Bovine Corneal Opacity and Permeability Test (BCOP) Eye Irritation Studies

• Isolated Chicken Eye Test Eye Irritation Studies

• In Vitro Ocular Irritation Test (EpiOcularTM) Eye Irritation Studies

• Direct Peptide Reactivity Assay (DPRA) Sensitization Studies/GPMT

• In Vitro Skin Irritation Test (EpiskinTM /EpidermTM ) Skin Irritation

• In Vitro Dermal absorption (EpiskinTM/EpidermTM ) / Human Cadaver Skin/Porcine skin/Cornea

Dermal Absorption (Rat andRabbit)

• In Vitro 3T3 NRU PhototoxicityIn Vivo Acute Phototoxicitystudies

• Local Lymph Node Assay (LLNA): BrdU-ELISA * Sensitization Studies/GPMT

Note:

* In Vivo Assay - Reduction of animals

• Testing as per the EU recommendation for Cosmetics

• Testing as per the requirements for Dermal Pharmaceuticals

• Testing as per the requirements for Consumer Healthcare products

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Quality Assurance & Archives

Test Item Control Office

Keeps custody & issuesOut all sponsor-supplied

samples

Document Archive

Archival of studyPlans & reports as

Per GLP requirement

Specimen Archive

Archival of studySpecimens as per GLP requirement

• Planning of QA activities

• Review of study plans, study reports and SOPs

• Conducts study based, process based and facility based inspections

• Reporting of inspection findings to Management and respective personnel

• Issue of QA statement in the Final report

• Archiving of QA and facility documents

• Regular GLP Training of staff

• Vendor/Supplier Audits

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Integrated Discovery ModelIntegration of Medicinal chemistry, DMPK, in vitro & in vivo biology

Medicinal Chemistry Services

• Rational design and synthesis of analogs

• Efficacy in multiple animal models

• Target engagement; PK-PD

• Human dose prediction; Dose Linearity

• Exploratory Toxicology & Safety

• Early assessment for pharmaceutical properties

Candidate selection

• SAR based optimization of lead molecules based on Potency, Selectivity & ADME properties

• PK and further ADME profile improvement

• In vivo efficacy evaluation

• Selection & scale-up of Lead candidate

Lead Optimization

• Identification of Hit and hit optimization

• Design of new scaffolds based on SAR

• Structure-based drug design

• Rational design of diverse libraries

• Route Scouting

• In vitro assays for potency & subtype selectivity

• Drugability studies to optimize SAR

• Evaluation of combined results

• Selection of Leads

Hit to lead

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Integrated Discovery Model

Integration of Medicinal chemistry, DMPK, in vitro & in vivo biology

FTE , FFS and other customized business models

Custom Synthesis and scale up

Milligram to gram scale synthesis

Route design & synthesis of novel

compounds

Advanced Intermediates

Reference Compounds, working standards

Metabolite synthesis and

Impurity synthesis

Including identification and isolation

Characterization of API/ NCE impurities

Non –GMP Scale-up

For Pre-clinical supplies supporting

GLP release Affordable Cost

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Process Chemistry Services

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Process Development and Optimization

•API and Advanced intermediates

•Working standards and potency assignments of NCEs

•Process Validation

•Analytical method development and validation

• Stability studies

• Impurity profiling, isolation, characterization, synthesis

Process Research

•Reduction in number of steps

•Cycle time reduction

• Scalable processes

•Elimination/replacement expensive raw materials

•Non-infringing processes

•What-if studies

•Robustness of the processes

•Process Demonstration

• IP generation (assigned to client)

Systems

PROJECT MANAGEMENT

On time delivery

Cost integration

High Quality

• A dedicated Project Manager for each project responsible for

Resource allocation

Logistics, shipment receipts

Reports, communication management

Timeline projection

• Technical teams interface directly with sponsor

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GALLERY

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Animal facility

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Analytical Lab

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Chemistry Lab

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Biopharma R&D Facility

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GLP Accredited Preclinical Development CenterDevarahosahally, Sompura Hobli, Nelamangala Tq,

Bengaluru Rural District-562111, Karnataka, INDIA

Tel: +91 816-2214400 | Contact No.: +91 9844457677

Email: bioneeds@bioneeds.in | Website: www.bioneeds.in

Chemistry & Biopharma R&D FacilityP-3, Peenya Industrial Area, 1st Main Road,

Peenya 1st Stage, Bengaluru-560058,

Karnataka, INDIA

Tel: +91 80-22658400

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Thank you!!!

Bioneeds India Private Limited