Transcript Hyderabad Population: 7.5 million Elevation: 536 m Capital City of

Welcome
to
Sapala Organics Private Limited
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Sapala Organics Pvt. Ltd.
“Offering Expertise in Organic Synthesis
for Cost-Effective
Research and Production, since 2007”
Quality Deliverables with Speed
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Content
1. Introduction
2. Business Model
3. Capabilities and Expertise
4. Chemistry Services offering
5. Advantage Sapala
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Introduction
Founders and Promoters:
Technical leaders from industries and academia across the globe
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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
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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
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Business Models
Fee for services :
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Predefined Deliverables.
Flexible option’s:
Client may choose any
Literature precedent for the preparation.
that’s suitable.
Mutually agreeable timelines.
Agreed cost (Resources + Raw Material Cost)
Full Time Equivalents (FTEs) Services:
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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.
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Team Sapala - Staff Breakup
Department
R&D
QC&A
Admin
Regular Staff - Designation
Group Leader
Research Scientist
Senior Scientific officer
Scientific officer
Sr. Chemist
Chemist
Trainee Chemist
R&D Total
Head QC&A
Senior scientific officer
Sr. Chemist
Chemist
Trainee Chemist
QC&A Total
General Manager
Manager (Finance & Accounts)
Accounts Executive
Executive HR
Building & Facility Supervisor
Supervisor-cum-Purchase Executive
Stores Assistant
General & House Keeping Supervisor
Office Assistant
Admin Total
Grand Total
Male Female Total
1
4
2
5
2
8
4
26
1
0
2
2
0
5
1
1
2
1
1
1
1
1
1
10
41
0
2
0
0
2
4
0
8
0
1
0
0
1
2
0
0
0
0
0
0
0
0
0
0
10
1
6
2
5
4
12
4
34
1
1
2
2
1
7
1
1
2
1
1
1
1
1
1
10
51
Contract
Grand
Male Female Total
Employees
Total
Student
Trainees
Guest
Researcher
5
1
0
2
7
1
8
1
0
1
1
0
1
Consultants
4
0
4
House
Keeping
15
6
21
Security
7
0
7
26
34
6
7
32
41
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Female
%
42
79
21
8
75
25
42
88
14
92
82
18
6
2
Student
Trainees
Male
%
Team Sapala
Total Strength: 51
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Technical Administrators : 2
Synthesis Lab – 34
Analytical – 07
Support Functions – 10 (HR, F&A, Purchase, Stores and Admin)
Min Qualification
Research
Experience
No
Ph. D
> 20 Yrs
2
Ph. D
> 10 Yrs
1
Ph. D
> 5 Yrs
6
Sr. Scientific Officer
MS
> 10 Yrs
2
Scientific Officer
MS
> 4 Yrs
5
Research Associate
MS
> 2 Yrs
20
Designation
Technical Administrators
Group Head
Research Scientist
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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.
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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%.
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Proven Experience
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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)
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Analytical Chemistry Support
Analytical Laboratory:
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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.
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Infrastructure
Synthesis Laboratory:
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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).
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Good Practices and SHE
• All scientist follow guidelines for Good Laboratory Practices.
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Project leaders regularly audit and correct deviations from
good laboratory practices.
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Strict compliance to Environment, Health and Safety.
Safety committee representing all laboratory unit monitors
compliance.
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Regular audits by internal representatives and external
experts.
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Good Practices and SHE
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Awareness programs and Training on various laboratory safety aspects
conducted routinely.
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Documentation of all unsafe incidents and learning from the same shared
with all employees.
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PPE with high safety standards are provided to all scientist.
All employees are covered under hospitalization and accident insurance.
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Project Management
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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).
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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.
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Documentation
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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.
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LNBs and supporting folder are audited regularly by QA / QC department for
their compliance.
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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.
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Advantage Sapala
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Rich experiences in drug discovery research and development
Key managers have extensive research experience in Japan and other
developed countries.
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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
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Project Life Cycle
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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.
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Contacts
USA
Japan
Dr. Yogesh S. Sanghvi
Dr. Masami Nakane
2802 Crystal Ridge Road
Encinitas, CA 92024 U.S.A.
124-1 Miyukiyama Tenpaku
Phone: 760.944.1541
Fax: 760.944.1543
cell: 7603107539
Phone and Fax: 81-52-836-6945
Nagoya Aichi 468-0075
Email: [email protected]
Email: [email protected]
EU
India
Dr. Md. K. Nazeeruddin
G. Sanjay
Station 6
Plot # 146B & 147, Phase-II,
Laboratory of Photonics and Interfaces (LPI)
IDA Mallapur, Uppal Mandal,
Institute of Chemical Science and Engineering
Kapra Muncipality, Hyderabad-500076
Faculty of Basic Science
(A.P), India. Mobile: +91-9963111463
Ecole Polytechnique Federale de Lausanne
Fax : + 91-40-27150601
CH-1015 Lausanne
Email:[email protected]
Switzerland
Tel +41 21 693 6124
Fax +41 21 693 4111
Email: [email protected]
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Thank you.
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