confidential welcome to sapala organics private limited
TRANSCRIPT
Confidential
Welcometo
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
1. Introduction
2. Business Model
3. Capabilities and Expertise
4. Chemistry Services offering
5. Advantage Sapala
Confidential
Introduction
Founders and Promoters:
Technical leaders from industries and academia across the globe
Confidential
Location
Hyderabad
Population: 7.5 million
Elevation: 536 m
Capital City of the Indian State of Andhra Pradesh
5th Largest Metropolis
Emerging IT and Biotech hub of India
Excellent pool of chemistry graduates
Centrally located with direct flights to international destinations
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 Breakup
Department Regular Staff - Designation Male Female TotalContract
EmployeesMale Female Total
Grand Total
Male %
Female %
Group Leader 1 0 1Research Scientist 4 2 6Senior Scientific officer 2 0 2Scientific officer 5 0 5Sr. Chemist 2 2 4Chemist 8 4 12Trainee Chemist 4 0 4
26 8 34 7 1 8
Head QC&A 1 0 1Senior scientific officer 0 1 1Sr. Chemist 2 0 2Chemist 2 0 2Trainee Chemist 0 1 1
5 2 7 1 0 1
General Manager 1 0 1Manager (Finance & Accounts) 1 0 1Accounts Executive 2 0 2Executive HR 1 0 1Building & Facility Supervisor 1 0 1Supervisor-cum-Purchase Executive 1 0 1Stores Assistant 1 0 1General & House Keeping Supervisor 1 0 1Office Assistant 1 0 1
10 0 10 26 6 3241 10 51 34 7 41 92 82 18
88 14
Student Trainees
1
21
75 25
0
81
79
5
0
6
2
1
42R&D
Admin Total
QC&A Total
Student Trainees
House Keeping
Consultants
Security
QC&A
7
Guest Researcher
0
R&D Total
2
Grand Total
42Admin 15 6 21
4 0 4
7
Confidential
Team Sapala
Total Strength: 51
• Technical Administrators : 2
• Synthesis Lab – 34
• Analytical – 07
• Support Functions – 10 (HR, F&A, Purchase, Stores and Admin)
Designation Min QualificationResearch
ExperienceNo
Technical Administrators Ph. D > 20 Yrs 2
Group Head Ph. D > 10 Yrs 1
Research Scientist Ph. D > 5 Yrs 6
MS > 10 Yrs 2
Scientific Officer MS > 4 Yrs 5
Research Associate MS > 2 Yrs 20
Sr. Scientific Officer
Confidential
Chemistry Capabilities
Synthetic and Medicinal Chemistry Support
• Hit identification enabling libraries
• Focused libraries for supporting Hit to Lead campaign
• Drug standards and reference compounds with ultra high purity
• Synthesis of building blocks and scaffolds enabling IP positioning
• Supply of hetero cyclic and natural product like scaffolds
• Synthesis of premium priced 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
Analytical Chemistry Support
Analytical Laboratory:
• FT NMR spectra for multi-nuclei (1H, 11C, 13C, 17O, 19F & 31P)
• 2D NMR Experiments (COSY, HETCOR, HMQC, NOESY)
• HPLC– 2 Nos (Jasco)
• LCMS – 1 No (Jasco)
• FTIR (JASCO)
• Gas Chromatography
• Specific Optical Rotation
• Chemical Methods of analysis
• Determination of physical properties.
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 and SHE
• All scientist follow guidelines for Good Laboratory Practices.
• Project leaders regularly audit and correct deviations from
good laboratory practices.
• Strict compliance to Environment, Health and Safety.
• Safety committee representing all laboratory unit monitors
compliance.
• Regular audits by internal representatives and external
experts.
Confidential
Good Practices and SHE
• 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.
• PPE with high safety standards are provided to all scientist.
• All employees are covered under hospitalization and accident insurance.
Confidential
Project Management
• Dedicated Project Manager :
o One point contact - Qualified Scientist (Ph D with Experience)
o Proactive Communication Daily / Weekly
o Responsible for all execution of scientific and technical guidelines
o Problem solving and knowledge input.
o 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:
o Quality Custom Synthesis / On-time delivery
o Timely communication in English (or Japanese)
o High information-security
o Affordable Cost
o Highest environmental and safety standards
o 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
ContactsUSA
Dr. Yogesh S. Sanghvi
2802 Crystal Ridge RoadEncinitas, CA 92024 U.S.A.
Phone: 760.944.1541Fax: 760.944.1543cell: 7603107539
Email: [email protected]
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: [email protected]
Japan
Dr. Masami Nakane
124-1 Miyukiyama Tenpaku
Nagoya Aichi 468-0075
Phone and Fax: 81-52-836-6945
Email: [email protected]
India
G. Sanjay
Plot # 146B & 147, Phase-II,
IDA Mallapur, Uppal Mandal,
Kapra Muncipality, Hyderabad-500076
(A.P), India. Mobile: +91-9963111463
Fax : + 91-40-27150601
Email:[email protected]
Confidential
Thank you.