focus on: contract development and manufacturing · process chemistry cgmp ... macromolecules. ......
TRANSCRIPT
Delivering
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The added Dimensionin Drug Discovery
Focus on: Contract Development and Manufacturing
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Jubilant Life Sciences
An integrated global Pharmaceutical & Life Sciences
● ‘Partner of Choice’ to global life sciences companies
● Low cost, multi location and vertically integrated supplier
● Strong relationships with 19 of top 20 Global Pharma companies & 7 of top 10 Global Agrochemical companies
● Among first few companies to be Responsible Care® 14001:2013 (RC 14001:2013) certified
40 Years
4 Decades of Rich Scientific Experience
6,700 Employees
● 1000 in R&D● 1400 in North America
11 Plants
Manufacturing Plants● 7 in India● 4 in North America
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Jubilant Life Sciences - Business Segmentation
Jubilant Life Sciences US $895.6 Million
Specialty Pharmaceuticals-Injectables
● Radiopharmaceuticals
● CMO of Sterile Injectables
● Allergy Therapy Products
Generics
● Solid Dosage Formulations
● Active Pharmaceutical I Ingredients (APIs)
● India Branded Pharmaceuticals
Specialty Intermediates &Nutritional Products
Specialty Intermediates
● Advance Intermediates
● Fine Ingredients
● Crop Science Ingredients
Nutritional Products
● Vitamins
● Animal Nutrition
Life Science Chemicals
● Life Science Chemicals
● Ethanol and Specialty Gases
● Chemistry services (Synthetic chemistry, Medicinal chemistry, Analytical chemistry and Process research/GMP)
● Computational chemistry
● Discovery Informatics
● Drug Metabolism and Pharmacokinetics
● In vitro / vivo biology
● In vivo biology
● Integrated drug discovery
● Structural biology
● Toxicology (GLP and Non GLP)
Pharmaceuticals Life Science Ingredients Drug Discovery Solutions
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Global Footprint
This illustration is not exhaustive. This illustration is not to scale.
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Innovative PartnerShips Across The Value Chain
MedicinalChemistryMedicinalChemistry
ComputationalChemistry
ComputationalChemistry
StructualBiology
StructualBiology
DMPKServicesDMPK
Services
ToxicologyServices
ToxicologyServices
DISCOVERYDISCOVERY
DEVELOPMENTDEVELOPMENT
CustomSynthesisCustom
Synthesis
GLPAnalyticalServices
GLPAnalyticalServices
GMPManufacturing
GMPManufacturing
ProcessResearch &
Development
ProcessResearch &
Development
CMCDocumentation
CMCDocumentation
COMMERCIALIZATIONCOMMERCIALIZATION
ProcessCharacterization
& Validation
ProcessCharacterization
& Validation
RegulatoryStarting
Materials
RegulatoryStarting
Materials
APIsAPIs
AdvancedIntermediates
AdvancedIntermediates
ProcessIntensification
ProcessIntensification
● R&D Centers: Noida & Bangalore● 400+ Scientists
● Pilot Plants: Noida & Gajraula● Reactors: 20+● Reactor Volumes: 20L – 1KL● 50+ Scientists
● 9 Multi Purpose Plants for Non-GMP / GMP Intermediates & Actives● Reactors: 100+● Reactor Volumes: 1KL to 14KL
Drug Filing with Global Regulatory Authorities
TargetIdeation
Lead Generation
Lead Optimization
CandidateSelection
Target Validation
Pre-clinicalAnimal Safety
Clinical Ph I Ph II Ph III
APIs & Intermediates
Product Launch
Manufacture Marketing/Phase IV
Integrated Project Management
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Discovery Services
Target to Lead Generation
● Structural Biology (Protein Science, X-ray, Crystallography)● Medicinal and Computational Chemistry● Screening & Profiling● Early ADMET & PK● In-vitro / In-vivo Pharmacology
Lead Optimization
● Medicinal Chemistry● DMPK● SBDD (Co-crystallization, Computational Modelling)● Target Engagement & Disease Models● Safety Profile (hERG, Nav 1.5)● Pre-formulation
Candidate Selection (IND)
● Process Chemistry cGMP● Scale-up & API● Genotox● Non-GLP Tox (rodent and dog*)● GLP Tox (rodent and dog*)● D2M predictions (WinNonlin)
Disease Biology Expertise
CNSMetabolic Disorder Pain & Inflammation (P&I)Oncology
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Developmental Chemistry Services
● Scaffolds, Building blocks, Intermediates, Reference compounds
● Asymmetric synthesis (Stereo-selective, enzymatic and resolution techniques)
● Impurity / Metabolite synthesis.
● Speciality Chemistry at Small Scales like Nucleosides , Small Peptides, Carbohydrates , Steroids, Macromolecules.
● Route Scouting & development
● Process design, development and optimisation (CMC)
● Salt screening and polymorph studies
● Process safety studies
● GMP and Non-GMP Material supplies for Tox, Pre-clinical, Phase I / II.
● Process Intensification Lab with Micro & Plug Flow Reactor.
● GLP Method developments
● Purifications (including chiral compounds)
● Stability studies (ICH)
● Solid State characterizations (DSC, TGA, XRD)
● Impurity profiling
● In Process Quality Control
Custom Synthesis Process Research / GMP Analytical Research
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Piloting Capabilities - Phase I and Phase II
End-to-end GMP production and processing of APIs / Final API for Animal tox / Phase- I / II Clinical material
● Manufacturing suites enabling 3 processes simultaneously
● Dedicated HVAC systems for each suite with single-pass air controls
● Dedicated Process areas, RM Store, Water system and FG Quarantine
● pH range 2 to 12 (Acidic & Basic)
● Reactor size 20- 100 L Glass / SS
● Wide range of process conditions for multi product manufacturing
● ISO-8 (Class 1,00,000) clean rooms for entire manufacturing operations
● Temperature, humidity & differential pressure controlled (Building Management System) areas Independent
● Batch size 500 g to ~10 kg
● Temperature range - 90 °C to 200 °C
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Key Differentiators
● Technology & Product Integration 35 years of integration experience GLP compliant R&D facilities
● Global Reach & Strong Customer Base
Product exports to over 100 countries Business with top innovators across various industries
● Global Leadership
All products evaluated on their strength & potential to attain global leadership
● Responsible Care 14001 Certification
LSI business certified under the American Chemistry Council’s (ACC) Responsible Care® program for Corporate Office, Noida & Gajraula Manufacturing Unit
● Strict Quality & Regulatory Compliance
Dedicated regulatory Team ensures In-house technologies to be non-infringing and compliance to global regulatory norms
● Business Excellence
Implementation of Business Excellence initiatives across all business functions - Six Sigma, Lean, DFSS, TPM, EPM, Sankalp, WCM, SCORE, CRM & Stage Gate in all SBUs.
● Environmental Health & Safety
Strong EHS initiatives
Focus on Process and Behaviour based safety
Dedicated Occupational Health Centre
Zero discharge facility
Valid Hazardous waste authorization
● Green Manufacturing Practices
Use of Green raw materials (Corn / Cane Ethanol) for majority of products. Results in lower carbon footprint compared to petroleum based manufacturing
● Sustainability
Corporate Sustainability Reporting for over 10 years with Multiple GRI A+ ratings.
● EcoVadis
Registered with EcoVadis for CSR evaluation with a gold rating for Gajraula manufacturing unit placing Jubilant as one of the Top 5% companies globally.
● JUBILANT BHARTIA FOUNDATION
Reaching out to 91 villages, 4.5 lakh people and over 14,000 students through primary education, basic healthcare & livelihood generation
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Key Differentiators
● Technology & Product Integration 35 years of integration experience GLP compliant R&D facilities
● Global Reach & Strong Customer Base
Product exports to over 100 countries Business with top innovators across various industries
● Global Leadership
All products evaluated on their strength & potential to attain global leadership
● Responsible Care 14001 Certification
LSI business certified under the American Chemistry Council’s (ACC) Responsible Care® program for Corporate Office, Noida & Gajraula Manufacturing Unit
● Strict Quality & Regulatory Compliance
Dedicated regulatory Team ensures In-house technologies to be non-infringing and compliance to global regulatory norms
● Business Excellence
Implementation of Business Excellence initiatives across all business functions - Six Sigma, Lean, DFSS, TPM, EPM, Sankalp, WCM, SCORE, CRM & Stage Gate in all SBUs.
● Environmental Health & Safety
Strong EHS initiatives
Focus on Process and Behaviour based safety
Dedicated Occupational Health Centre
Zero discharge facility
Valid Hazardous waste authorization
● Green Manufacturing Practices
Use of Green raw materials (Corn / Cane Ethanol) for majority of products. Results in lower carbon footprint compared to petroleum based manufacturing
● Sustainability
Corporate Sustainability Reporting for over 10 years with Multiple GRI A+ ratings.
● EcoVadis
Registered with EcoVadis for CSR evaluation with a gold rating for Gajraula manufacturing unit placing Jubilant as one of the Top 5% companies globally.
● JUBILANT BHARTIA FOUNDATION
Reaching out to 91 villages, 4.5 lakh people and over 14,000 students through primary education, basic healthcare & livelihood generation
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D The added Dimensionin Drug Discovery
Jubilant Biosys Limited
Bengaluru Research Site:
#96, Industrial Suburb 2nd Stage, Yeshwantpur Bangalore - 560 022 Karnataka India.
Tel: +91 80 66628400
Noida Research Site:
B-34, Sector 58, Noida, Uttar Pradesh 201301
Tel: +91 120 409 3300
For more information:[email protected]
Thank you for your time