Sreeni Labs Profile
- 1. Sreeni Labs …Adding value Sreeni Labs Private Limited Road No:12, Plot NO: 24,25 & 26 IDA, Nacharam, Hyderabad - 500 076 Telangana, India e-mail: Info@sreenilabs.com
- 2. • Established in 2007 • Located in Hyderabad, India • Contract Research and Manufacturing • FTE and Fee for Service About us Vision • “To become trusted partner globally for pharmaceutical companies in advancing their discovery and development efforts to deliver medicines that protect and improve human and animal health conditions” Mission • “To provide innovative, value-added and cost effective synthetic, medicinal and process chemistry services & Supply quality products that help speed up drug discovery and development programs” Values • Integrity • Respect • Customer focus • Innovation
- 3. 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 scale to enable rapid preclinical development. • Route Selection: Design & demonstrate synthetic routes with a potential to become commercial route to clinical candidates and leading key intermediates. • Route Development: Develop an existing or chosen route from a proof of concept, and transfer the technology to pilot plant for a successful scale up with 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 scale to enable rapid preclinical development. • Route Selection: Design & demonstrate synthetic routes with a potential to become commercial route to clinical candidates and leading key intermediates. • Route Development: Develop an existing or chosen route from a proof of concept, and transfer the technology to pilot plant for a successful scale up with a good control on impurities. • Custom Synthesis & Manufacturing: Synthesize building blocks, impurities, metabolites, reference standards, bench mark compounds, and rare chemicals.
- 5. 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 scale 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
- 6. • 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)
- 7. 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)
- 8. 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 alliance partner(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 alliance partner(s) facility on exclusive basis
- 9. Lab Safety Safety is number one priority Labs are fitted with Fire extinguishers, eye washer etc., Wearing lab coats, safety glasses, gloves compulsory Safety shields are used for hazardous rxns and high temp rxns All personal go through general laboratory safety training at the time of induction and also refreshed periodically Waste Treatment & Disposal All the liquid waste segregated as chlorinated / non-chlorinated types Solid waste like silica gel, sodium sulfate etc. kept separately Aqueous waste evaporated or disposed at JETL and solid waste disposed at a Gov.t regulated disposal site Infrastructure – Safety and Environment Safety is number one priority Labs are fitted with Fire extinguishers, eye washer etc., Wearing lab coats, safety glasses, gloves compulsory Safety shields are used for hazardous rxns and high temp rxns All personal go through general laboratory safety training at the time of induction and also refreshed periodically All the liquid waste segregated as chlorinated / non-chlorinated types Solid waste like silica gel, sodium sulfate etc. kept separately Aqueous waste evaporated or disposed at JETL and solid waste disposed at a Gov.t regulated disposal site
- 10. 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 Cost effectiveness Thorough Data and Documentation Meeting Timelines • Most efficient synthetic routes • Optimization using less expensive reagents • Complete experimental procedures and spectral data for use in regulatory filings
- 11. Each Project is given a project code All projects reviewed by Project in Charge every 15 days Client receives weekly/ biweekly progress reports Purity of final compounds discussed with client before shipping in case of problem in achieving Targeted purity Data cards are prepared for each step of the synthetic process and compiled for Final report Efficient Project Management Project planning by Scientists and execution Scientists follow up the progress on a daily basis Chemists record their observations in dedicated Lab Note books All projects reviewed by Project in Charge every 15 days Data cards are prepared for each step of the synthetic process and compiled for Final report Final reports sent to Client for each project which includes synthetic scheme, experimental procedure, spectral data such as IR, 1H NMR, Mass and HPLC in electronic form.
- 12. • 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 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
- 13. • 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, and avoided 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 the number of steps by 50% and scaled up on multi kilo scale. Avoided use of palladium catalyst and expensive 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 synthetic steps 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 SAR program. 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 on 100kg 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 of thiophenes, 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, and avoided 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 the number of steps by 50% and scaled up on multi kilo scale. Avoided use of palladium catalyst and expensive 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 synthetic steps 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 SAR program. 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 on 100kg 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 of thiophenes, imidazoles, oxazoles, isoxazoles, quinolines and pyridines. Clients: US/Europe/Domestic based pharma ; References can be provided upon request
- 14. Lab Capacity: • SREENI Labs facility can accommodate 80 to 100 Scientists / Chemists. Total five R&D wet Labs, Analaytical lab & a Scale up lab. Each R&D lab can accommodate 15-16 People. • Present total SREENI Labs staff is 35. Out of five Labs, two labs are in operation and are occupied with 22 chemists. 3 chemists are working in kilo lab. Total supporting staff is 10 people which include the office staff. • SREENI Labs can accommodate still another 70 people easily and can execute work 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 any special equipment needs. Lab Capability – A Glimpse Lab Capacity: • SREENI Labs facility can accommodate 80 to 100 Scientists / Chemists. Total five R&D wet Labs, Analaytical lab & a Scale up lab. Each R&D lab can accommodate 15-16 People. • Present total SREENI Labs staff is 35. Out of five Labs, two labs are in operation and are occupied with 22 chemists. 3 chemists are working in kilo lab. Total supporting staff is 10 people which include the office staff. • SREENI Labs can accommodate still another 70 people easily and can execute work 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 any special equipment needs.
- 15. Recent Photographs of new premises– A Glimpse Front view of the SREENI LABS Main corridor in the first floor to enter into the Labs, QC and other FacilitiesConference Room area
- 16. Recent Photographs of new premises– A Glimpse QC –over all view & a closer look of GC , HPLC / LCMS
- 17. Recent Photographs of new premises– A Glimpse Lab Look from middle corridor Kilo Lab under development Generator for power Back up
- 18. Contact Info For Enquiries & Communications Dr. Sreenivasa R. Mundla Managing Director Sreeni Labs Private Limited Road No:12, Plot NO: 24,25 & 26 IDA, Nacharam Hyderabad, 500 076; Telangana State India, e-mail: sreeni@sreenilabs.com Info@sreenilabs.com Ph: 011-91-98660 92626 THANKS Dr. Sreenivasa R. Mundla Managing Director Sreeni Labs Private Limited Road No:12, Plot NO: 24,25 & 26 IDA, Nacharam Hyderabad, 500 076; Telangana State India, e-mail: sreeni@sreenilabs.com Info@sreenilabs.com Ph: 011-91-98660 92626 THANKS