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Confidential. Welcome to Sapala Organics Private Limited. Confidential. Sapala Organics Pvt. Ltd. “Offering Expertise in Organic Synthesis for Cost-Effective Research and Production, since 2007” Quality Deliverables with Speed . Confidential. Content. Introduction Business Model
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Confidential Welcome to Sapala Organics Private Limited
Confidential Sapala Organics Pvt. Ltd. “Offering Expertisein Organic Synthesis for Cost-Effective Research and Production, since 2007” Quality Deliverables with Speed
Confidential Content Introduction Business Model Capabilities and Expertise Chemistry Services offering Advantage Sapala
Confidential Introduction Founders and Promoters: Technical leaders from industries and academia across the globe
Confidential Mission and Vision Vision: To be a Respected Contract Research Organisation (CRO) contributing to the society Mission: To be an organization skilled in organic synthesis and a partner of choice for diverse customers
Confidential Business Models Fee for services : • Predefined Deliverables. • Literature precedent for the preparation. • Mutually agreeable timelines. • Agreed cost (Resources + Raw Material Cost) Full Time Equivalents (FTEs) Services: • Dedicated resources and laboratory infrastructure at Sapala • Flexibility of work plans (WPs) and deliverables to client. • Client can change priority of WPs as per internal development. • Dedicated Project Manager – One point contact at Sapala. • Agreed FTE cost per annum inclusive of solvents, routine chemicals and disposable items for daily operations ( upto 10 g level). • Special reagents specific for the project charged separately. Flexible option’s: Client may choose any that’s suitable.
Confidential Team Sapala – Staff Break Up Technical Group 70 Support Group 55 125
Confidential Chemistry Capabilities Synthetic and Medicinal Chemistry Support • Focused libraries for supporting Hit to Lead campaign • Drug standards and reference compounds with high purity • Synthesis of building blocks and scaffolds enabling IP positioning • Supply of hetero cyclic and natural product like scaffolds • Synthesis of structurally attractive reagents and intermediates for med-chem support Material Chemistry Support • Synthesis of Dyes for photo-functional applications. • Synthesis of organic compounds for their application as nano tubes and electro / photochemical switches.
Confidential Chemistry Capabilities Process Research and Scale up: • Route scouting. • Optimization of reaction and unit processes. • Optimization of processes for scale up from gm to Kg. • Run single campaign based on Tech Pack (quick and dirty). Analytical Chemistry : • Analytical Method development and Validation. • Spectroscopic analysis. • Purification of high value material to achieve purity levels > 99.5%.
Confidential Proven Experience • Library synthesis • Intermediates for drug candidates • Reference compounds and Pharmaceutical Standards • Drug metabolites, or degradation products • Fluoro-, Alkylated-, carbohydrate synthesis • Nucleoside chemistry, including synthesis of phosphoamidate • Preparation of boronate reagents not described in literatures • Bio-Organic transformations • Multi step synthesis on large scale (15 steps 100 gm delivery)
Confidential Instrumentation • FT NMR spectra for multi-nuclei (1H, 13C, 19F, 31P) • 2D NMR Experiments (COSY, HETCOR, HMQC, NOESY) • HPLC-1 No (Agilent) • HPLC– 2 Nos (Jasco) + 1 No Prep HPLC (Jasco) • LC/MS – 1 No (Shimadzu) • FTIR (JASCO) • Gas Chromatography analysis • Specific Optical Rotation • Medium Pressure Flash Column Chromatography (Grace-Davison) • UV Spectrophotometer ( Jasco ) • Lyophilizer ( Labconco )
Confidential Infrastructure Synthesis Laboratory: • Modular Laboratories with standard equipments and instruments • Fume hoods • Walk in fume hoods • Rotary evaporators • Prep HPLC purification system • Flash chromatographic purification • Humidity controlled facility • Reaction performance temp range -78 to +200 °C • Analytical instruments (NMR, HPLC, LCMS-MS and GC).
Confidential Good Practices • Standard guidelines for safety and lab work. • Regular audit and correct deviations from prescribed standards as per SOP. • Strict compliance to Environment, Health and Safety. • Safety committee representing all laboratory unit monitors compliance. • Regular audits by internal representatives and external experts. • Awareness programs and Training on various laboratory safety aspects conducted • routinely. • Documentation of all unsafe incidents and learning from the same shared with all • employees. • Personal Protective Equipment with high safety standards are provided to all scientists. • Hospitalization and accident insurance covering.
Confidential Project Management • Dedicated Project Manager : • One point contact - Qualified Scientist (Ph D with Experience) • Proactive Communication Daily / Weekly • Responsible for all execution of scientific and technical guidelines • Problem solving and knowledge input. • Controls access to tech pack by team (need to know basis). • Receptive to change of work plan priority as per the clients need. • Weekly update / bi weekly report - teleconference. • Quarterly evaluation of the FTE program for productivity and efficiency. • Video conference. • Site visit by client as well as by Sapala PM – yearly once.
Confidential Documentation • Laboratory note books (LNBs) issued for all FFS and FTE project. • SOP for writing LNBs – Compliance is mandatory. • Orderly upkeep of supporting information (Spectroscopic data and literature) in separate folder with appropriate identification. • LNBs and supporting folder are audited regularly by QA / QC department for their compliance. • Weekly / fortnightly updates to track progress. • Structured QA / QC reports • Project report is submitted upon completion – details goals and suggested path, if any alteration and modifications in the same to complete the project. Highlights if any additional information or knowledge is generated.
Confidential Advantage Sapala • Rich experiences in drug discovery research and development • Key managers have extensive research experience in Japan and other developed countries. • Japanese project management coupled to Indian research teams. • Full analytical capabilities for synthesis on site • Customers’ satisfaction: • Quality Custom Synthesis / On-time delivery • Timely communication in English (or Japanese) • High information-security • Affordable Cost • Highest environmental and safety standards • International ethical standards
Confidential Project Life Cycle • Sign Confidentiality Disclosure Agreement. • Evaluate RFQ / RFP. • Propose details of the approaches to the deliverables including quotation. • Sign research / production agreement with clearly defined terms and conditions. • Appoint a dedicated scientific project manager. • Update weekly and biweekly to client after the initiation of the project. • Communicate with regular teleconference or video conference. • Deliver on time the deliverables to client. All IPR generated during the project execution is owned by the client.
Confidential Contacts USA Dr. Yogesh S. Sanghvi 2802 Crystal Ridge RoadEncinitas, CA 92024 U.S.A. Phone: 760.944.1541Fax: 760.944.1543cell: 7603107539 Email: yogeshss@sapalaorganics.com EU Dr. Md. K. Nazeeruddin Station 6 Laboratory of Photonics and Interfaces (LPI) Institute of Chemical Science and Engineering Faculty of Basic Science Ecole Polytechnique Federale de Lausanne CH-1015 Lausanne Switzerland Tel +41 21 693 6124 Fax +41 21 693 4111 Email: s.nazeeruddin@heliochemicals.ch Japan Dr. Masami Nakane 124-1 Miyukiyama Tenpaku Nagoya Aichi 468-0075 Phone and Fax: 81-52-836-6945 Email: masami.nakane@sapalaorganics.com India G. Sanjay Plot # 146B & 147, Phase-II, IDA Mallapur, UppalMandal, KapraMuncipality, Hyderabad-500076 (A.P), India. Mobile: +91-9963111463 Fax : + 91-40-27150601 Email:sanjayg@sapalaorganics.com
Confidential Thank you.