sreeni labs profile
TRANSCRIPT
Sreeni Labs…Adding value
Sreeni Labs Private LimitedRoad No:12, Plot NO: 24,25 & 26IDA, Nacharam,Hyderabad - 500 076 Telangana, Indiae-mail: [email protected]
• Established in 2007• Located in Hyderabad, India• Contract Research and Manufacturing• FTE and Fee for Service
About us
Vision
• “To become trustedpartner globally forpharmaceutical companiesin advancing theirdiscovery and developmentefforts to deliver medicinesthat protect and improvehuman and animal healthconditions”
Mission
• “To provide innovative,value-added and costeffective synthetic,medicinal and processchemistry services &Supply quality productsthat help speed up drugdiscovery and developmentprograms”
Values
• Integrity• Respect• Customer focus• Innovation
Medicinal Chemistry Process Development Manufacturing
• Medicinal Chemistry: Design & synthesize select medchem target compounds,analogs & compound libararies.
• Enabling Chemistry: Design strategic synthetic routes to NCEs, new scaffolds/platforms & key advanced intermediates and demonstrate on multi-gram scaleto enable rapid preclinical development.
• Route Selection: Design & demonstrate synthetic routes with a potential tobecome commercial route to clinical candidates and leading key intermediates.
• Route Development: Develop an existing or chosen route from a proof ofconcept, and transfer the technology to pilot plant for a successful scale upwith a good control on impurities.
• Custom Synthesis & Manufacturing: Synthesize building blocks, impurities,metabolites, reference standards, bench mark compounds, and rare chemicals.
Supporting Drug Discovery and DevelopmentSupporting Discovery to Development
• Medicinal Chemistry: Design & synthesize select medchem target compounds,analogs & compound libararies.
• Enabling Chemistry: Design strategic synthetic routes to NCEs, new scaffolds/platforms & key advanced intermediates and demonstrate on multi-gram scaleto enable rapid preclinical development.
• Route Selection: Design & demonstrate synthetic routes with a potential tobecome commercial route to clinical candidates and leading key intermediates.
• Route Development: Develop an existing or chosen route from a proof ofconcept, and transfer the technology to pilot plant for a successful scale upwith a good control on impurities.
• Custom Synthesis & Manufacturing: Synthesize building blocks, impurities,metabolites, reference standards, bench mark compounds, and rare chemicals.
Solidinfrastructure
Customercentricculture
Scientificskillskey
differentiator
SreeniLabs
Why Sreeni Labs
Customercentricculture
EfficientProject
Management
Scientificskillskey
differentiator
SreeniLabs
Lab and Scale up equipment
• Bench top fume hoods fitted with air, N2, water, vacuum lines
• Distillation fume hoods
• Rota vapors/ High vacuum and diaphragm pumps
• Parr hydrogenation apparatus/ 2L Autoclave (SS)
• Ice machine, dry ice & Liquid Nitrogen
• UV cabinets and balances
• 20 L Rotary Evaporator
Infrastructure – Lab scaleLab and Scale up equipment
• Bench top fume hoods fitted with air, N2, water, vacuum lines
• Distillation fume hoods
• Rota vapors/ High vacuum and diaphragm pumps
• Parr hydrogenation apparatus/ 2L Autoclave (SS)
• Ice machine, dry ice & Liquid Nitrogen
• UV cabinets and balances
• 20 L Rotary Evaporator
• LCMS (Agilent)
• HPLC (Waters) / GC (shimadzu)
• FT IR (Thermo-Fisher Scientific)/ Melting Point (Buchi)
• Water purification (Millipore)
• Micro balances/ Polarimeter / pH meter/ Sonicator/ Karl-Fischer Titrator
• Access to 300 MHz NMR (Fee for service basis)
Infrastructure – Analytical
• LCMS (Agilent)
• HPLC (Waters) / GC (shimadzu)
• FT IR (Thermo-Fisher Scientific)/ Melting Point (Buchi)
• Water purification (Millipore)
• Micro balances/ Polarimeter / pH meter/ Sonicator/ Karl-Fischer Titrator
• Access to 300 MHz NMR (Fee for service basis)
Multi purpose pilot plant:
• All Glass reactors: 100 L (2), 50L (1) & 20L (1)
• SS Reactors: 500L
• High Vaccum Distillation
• Nutch Filters
• Vaccum Tray Dryer (SS)
• Water Jet Vacum Pump
• Cooling Tower
• SS Autoclave (2 L)
Infrastructure – Pilot Plant
Multi purpose pilot plant:
• All Glass reactors: 100 L (2), 50L (1) & 20L (1)
• SS Reactors: 500L
• High Vaccum Distillation
• Nutch Filters
• Vaccum Tray Dryer (SS)
• Water Jet Vacum Pump
• Cooling Tower
• SS Autoclave (2 L)
Bulk Production Operations**:• SS Reactors: 1 KL to 10 KL
• GL Reactors: 1.6 KL to 6 KL
• Associated utilities to carry out all kinds of reactions
**Note: All commercial scale operations are carried out at our alliancepartner(s) facility on exclusive basis
Infrastructure - Manufacturing
Bulk Production Operations**:• SS Reactors: 1 KL to 10 KL
• GL Reactors: 1.6 KL to 6 KL
• Associated utilities to carry out all kinds of reactions
**Note: All commercial scale operations are carried out at our alliancepartner(s) facility on exclusive basis
Lab Safety
Safety is number one priorityLabs are fitted with Fireextinguishers, eye washer etc.,Wearing lab coats, safety glasses,gloves compulsorySafety shields are used for hazardousrxns and high temp rxnsAll personal go through generallaboratory safety training at the timeof induction and also refreshedperiodically
Waste Treatment & Disposal
All the liquid waste segregated aschlorinated / non-chlorinated typesSolid waste like silica gel, sodiumsulfate etc. kept separatelyAqueous waste evaporated ordisposed at JETL and solid wastedisposed at a Gov.t regulateddisposal site
Infrastructure – Safety and Environment
Safety is number one priorityLabs are fitted with Fireextinguishers, eye washer etc.,Wearing lab coats, safety glasses,gloves compulsorySafety shields are used for hazardousrxns and high temp rxnsAll personal go through generallaboratory safety training at the timeof induction and also refreshedperiodically
All the liquid waste segregated aschlorinated / non-chlorinated typesSolid waste like silica gel, sodiumsulfate etc. kept separatelyAqueous waste evaporated ordisposed at JETL and solid wastedisposed at a Gov.t regulateddisposal site
Confidentiality• IP belongs to customer• Data protection measures
• Upfront discussion and agreement• Any issues will be intimated
immediately with a proposed solution
Customer Centric approach
Customer Costeffectiveness
Thorough Dataand
Documentation
MeetingTimelines
• Most efficient synthetic routes• Optimization using less expensive
reagents
• Complete experimentalprocedures and spectral data foruse in regulatory filings
Each Project is given aproject code
All projects reviewed by Projectin Charge every 15 days
Client receives weekly/biweekly progress reports
Purity of final compounds discussed withclient before shipping in case of problem inachieving Targeted purity
Data cards are prepared for each step ofthe synthetic process and compiled forFinal report
Efficient Project Management
Project planning byScientists and execution
Scientists follow up theprogress on a dailybasis
Chemists record theirobservations in dedicated LabNote books
All projects reviewed by Projectin Charge every 15 days
Data cards are prepared for each step ofthe synthetic process and compiled forFinal report
Final reports sent to Client for each projectwhich includes synthetic scheme,experimental procedure, spectral data suchas IR, 1H NMR, Mass and HPLC in electronicform.
• Proven track record in the design and development of practical, safe, economical and scalableroutes to a variety of New Chemical Entities & natural products synthesis
• Generation of enolates using LDA or LHMDS & preparation of enamine
• Suzuki, Buchwald chemistry using Pd based reagents
• Various acid-amine / acid- alcohol condensations
• Reductive aminations using NaBH3CN, NaBH (OAc)3, etc.
• Grignard & Wittig reactions, Mitsunobu rxns, protection & deprotections
• General reactions like oxidations using PCC, PDC, SeO2, Swern oxdn and several other reagents;
• Reductions using Metal / acid, LAH, NaBH4, Dibal-H etc.,
• Hydrogenation using 250 mL- 2L Parr hydrogenation apparatus
• Hazardous Chemistry such as nitration, Cyanations, Phosgene & liq. ammonia reactions
• Asymmetric synthesis, Chemical Resolutions
• Use of Amino acids in making chiral building blocks
• Process impurities & Metabolites
• Total synthesis of terpenoids & Alkaloids
Scientific Skills – A Glimpse• Proven track record in the design and development of practical, safe, economical and scalable
routes to a variety of New Chemical Entities & natural products synthesis
• Generation of enolates using LDA or LHMDS & preparation of enamine
• Suzuki, Buchwald chemistry using Pd based reagents
• Various acid-amine / acid- alcohol condensations
• Reductive aminations using NaBH3CN, NaBH (OAc)3, etc.
• Grignard & Wittig reactions, Mitsunobu rxns, protection & deprotections
• General reactions like oxidations using PCC, PDC, SeO2, Swern oxdn and several other reagents;
• Reductions using Metal / acid, LAH, NaBH4, Dibal-H etc.,
• Hydrogenation using 250 mL- 2L Parr hydrogenation apparatus
• Hazardous Chemistry such as nitration, Cyanations, Phosgene & liq. ammonia reactions
• Asymmetric synthesis, Chemical Resolutions
• Use of Amino acids in making chiral building blocks
• Process impurities & Metabolites
• Total synthesis of terpenoids & Alkaloids
• Synthesized ~60 Retinal analogs on 100mg scale, 50 reference compounds from 100mg to 1g scale.
• In four months time, developed a novel non Suzuki route to an aryl-heteroaryl API in phase II, andavoided use of palladium catalyst &expensive ligands. This resulted in cost reduction of API by 70%.
• Designed & developed an acid-base chemistry route to an oncology product and lowered thenumber of steps by 50% and scaled up on multi kilo scale. Avoided use of palladium catalyst andexpensive ligands and also reduced the cycle time by 65%.
• Proposed and developed a novel route for an API and avoided use of reagents like sodium azide,methyl iodide and zinc chloride towards the end of synthesis. This helped to lower the syntheticsteps and also avoided the need to test for potential mutagens in the API.
• In 6 weeks time designed & developed a novel synthetic route for a key intermediate in SARprogram. A well established major CRO couldn’t make this product after 4 months of 2 FTE efforts.
• Developed novel process for a tetrapeptide synthesis in solution phase. Chemistry was scaled up on100kg scale.
• In two months time made variously substituted >50 sulfonyl fluorides on 25 to 50g scale.
• Synthesized more than 400 building blocks from 10g to 1kg scale comprising derivatives ofthiophenes, imidazoles, oxazoles, isoxazoles, quinolines and pyridines.
Scientific Skills – A Glimpse• Synthesized ~60 Retinal analogs on 100mg scale, 50 reference compounds from 100mg to 1g scale.
• In four months time, developed a novel non Suzuki route to an aryl-heteroaryl API in phase II, andavoided use of palladium catalyst &expensive ligands. This resulted in cost reduction of API by 70%.
• Designed & developed an acid-base chemistry route to an oncology product and lowered thenumber of steps by 50% and scaled up on multi kilo scale. Avoided use of palladium catalyst andexpensive ligands and also reduced the cycle time by 65%.
• Proposed and developed a novel route for an API and avoided use of reagents like sodium azide,methyl iodide and zinc chloride towards the end of synthesis. This helped to lower the syntheticsteps and also avoided the need to test for potential mutagens in the API.
• In 6 weeks time designed & developed a novel synthetic route for a key intermediate in SARprogram. A well established major CRO couldn’t make this product after 4 months of 2 FTE efforts.
• Developed novel process for a tetrapeptide synthesis in solution phase. Chemistry was scaled up on100kg scale.
• In two months time made variously substituted >50 sulfonyl fluorides on 25 to 50g scale.
• Synthesized more than 400 building blocks from 10g to 1kg scale comprising derivatives ofthiophenes, imidazoles, oxazoles, isoxazoles, quinolines and pyridines.
Clients: US/Europe/Domestic based pharma ; References can be provided upon request
Lab Capacity:
• SREENI Labs facility can accommodate 80 to 100 Scientists / Chemists. Totalfive R&D wet Labs, Analaytical lab & a Scale up lab. Each R&D lab canaccommodate 15-16 People.
• Present total SREENI Labs staff is 35. Out of five Labs, two labs are in operationand are occupied with 22 chemists. 3 chemists are working in kilo lab. Totalsupporting staff is 10 people which include the office staff.
• SREENI Labs can accommodate still another 70 people easily and can executework as it is having a proven record with the able leadership.
• SREENI Labs uses Reaxys and electronic journals for its literature requirements.
• SREENI Labs utilizes IICT, Hyderabad facility for ant additional literature and anyspecial equipment needs.
Lab Capability – A Glimpse
Lab Capacity:
• SREENI Labs facility can accommodate 80 to 100 Scientists / Chemists. Totalfive R&D wet Labs, Analaytical lab & a Scale up lab. Each R&D lab canaccommodate 15-16 People.
• Present total SREENI Labs staff is 35. Out of five Labs, two labs are in operationand are occupied with 22 chemists. 3 chemists are working in kilo lab. Totalsupporting staff is 10 people which include the office staff.
• SREENI Labs can accommodate still another 70 people easily and can executework as it is having a proven record with the able leadership.
• SREENI Labs uses Reaxys and electronic journals for its literature requirements.
• SREENI Labs utilizes IICT, Hyderabad facility for ant additional literature and anyspecial equipment needs.
Recent Photographs of new premises– A Glimpse
Front view of the SREENI LABS
Main corridor in the first floor to enter into theLabs, QC and other FacilitiesConference Room area
Recent Photographs of new premises– A Glimpse
QC –over all view & acloser look of GC ,HPLC / LCMS
Recent Photographs of new premises– A Glimpse
Lab Look from middle corridor
Kilo Lab under development Generator for power Back up
Contact Info For Enquiries & Communications
Dr. Sreenivasa R. MundlaManaging Director
Sreeni Labs Private LimitedRoad No:12, Plot NO: 24,25 & 26
IDA, NacharamHyderabad, 500 076; Telangana State
India,e-mail: [email protected]
Ph: 011-91-98660 92626
THANKS
Dr. Sreenivasa R. MundlaManaging Director
Sreeni Labs Private LimitedRoad No:12, Plot NO: 24,25 & 26
IDA, NacharamHyderabad, 500 076; Telangana State
India,e-mail: [email protected]
Ph: 011-91-98660 92626
THANKS