integrated discovery, development & medical devices ...€¦ · integrated discovery,...
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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: [email protected] | 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