Rainbow-Chem · Customer Synthesis • Drug discovery & preclinical development support •...

25-Jun-18 1Shanghai Rainbow Chemistry Co., Ltd

Rainbow-ChemInnovative Solutions for Discovery

Contents

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INTRODUCTION

R&D STRENGTH

INFRASTRUCTURE

RESOURCES & CORE TEAM

CUSTOMERS

Rainbow-Chem 瑞博化学Innovative Solutions for Discovery


Introduction

Organization ChartBoard of Director

CEO

QA Department R&D Center

R&D

Dep

artm

ent

R&D

1

R&D

2

Proc

ess

Dep

artm

ent

Proc

ess 1

Proc

ess 2

Prod

uctio

n D

epar

tmen

t

Finance Department COO

Mar

ketin

g D

epar

tmen

t

E

H

S

Anal

ytic

al C

ente

r

PM D

epar

tmen

t

Proc

urem

ent

Dep

artm

ent

Logi

stic

Cen

ter

HR

Dep

artm

ent

Technical Committee


Introduction

Headquarter and R&D center: Zhangjiang High-Tech Park, Pudong District, Shanghai

Main business:• Research, development and production of APIs, advanced intermediates and fine chemicals • Customer synthesis service from lab scale to pilot plant production

• Process research and optimization

• Providing customers with integrated, cost-effective and efficient services from clinical stage to commercial production. Aiming to help global customers to reduce cost on drug research & development as well as the production

Shanghai Rainbow Chemistry Co., LtdSince June 2008

5

Founded in Xuhui District, Shanghai. R&D area was expanded to 1300m2. R&D team construction was completed. GMP qualified joint production base was established.

More than 1000 pharmaceutical intermediates were produced. Passed customers’ audits. Tens of products were scaled up. More than 10 APIs were developed. Became top pharmaceutical companies’ vendor.

Relocated to the Zhang Jiang Hi-tech Park, Pudong New Area, Shanghai and expanded the R&D center, Kilo Lab, QC center, and warehouse, and established GLP management system.

2008-2012

2013-2015

20162017

Milestones

Shanghai Rainbow Chemistry Co., Ltd25-Jun-18

2018

Specializes in CDMO business including process R&D, process optimization and modification, and production under enhanced quality management system and is a supplier of starting materials, advanced intermediates, and API for domestic and international pharmaceutical companies.


Introduction

Certificates

• We have had numbers of patents

• Certified by ISO9001:2008 Quality Management System

• Awarded as the High Technology Company


Our R&D Strength

Rainbow Production from R&D – Kilo Lab – Manufactoring

Small scale Kgs 100 Kgs

Process research, Development and Optimization

• Route scouting, including innovative solution to complex synthetic problem (photochemical reaction, high pressure reaction, cryogenic reaction)

• Critical process parameter evaluation• Technology transfer to manufacturing

production• Safety evaluation/hazard assessment

Research and Development in Manufacturing• Advanced intermediates, Registration Staring

Materials and API• Process development and technical support

for commercialization

CMC Support• Registration of Starting Material Strategy• Impurity Management: fate and linkage• Potential Genotoxic Impurity Management

Customer Synthesis• Drug discovery & preclinical development

support• Synthesis of impurity marker


Products API intermediates: Rainbow provides with hundreds of API intermediates. A number of products have entered the phases of clinical trial.

Compounds: Heterocyclic Boronic Acid Series, Chiral Chemical Series, Aromatic Series, Photochemical Reaction Series, total 1000 compounds.

Intermediates Support for Phase of Clinical Trial

Intermediates Support for Phase of Clinical Trial

RB3018 Phase III RB3440 Phase III

RB3499 Approved RB4055 Phase I

RB3324 Phase III RB3432 Phase II

RB3405 Phase II RB4050 Phase I

RB3421 Phase II RB3588 Phase I

RB3325 Phase I RB3597 Phase I

Our R&D Strength


Products Building blocks (manufactured over 100kg-scale)

Our R&D Strength


Generic Drug Substance Development

• Route selection is completed independently. The products covers many fields, e.g. anti-tumor, antivirus, cardiovascular, anti-depressant, poliomyelitis etc.

• In addition to technical routes and high quality intermediates, Rainbow also provides related impurities in accordance with customer requirements.

Drug name Related intermediatesOlaparib RB3463，RB3259，RB3531

Brexpiprazole RB3307， RB3505，RB3506

Baricitinib RB3559， RB2139，RB3552，RB3551

Our R&D Strength


Generic Drug Substance Development

Our R&D Strength


Research and Development CenterCarry out process R&D, process optimization, and production services at different stages

R&D Department：Development of targeted compounds, development of advanced pharmaceutical intermediates.

Process Department：Process research, development, and optimization. Technology transfer from R&D lab to manufacturing site.

Production Department：Scaleup production, safety assessment, cost control, and waste management.

Our Infrastructure


Kilo Lab Kilo Lab has 14 walk-in fume hoods, nearly 300 m², equipped with 20-100L different glass reaction kettle, 30-50L rotavap, vacuum pump, low temperature (-100 ℃) circulating pump, and high-temperature heat system (200 ℃), which can carry out the pilot process optimization work and manufacturing simulation work.

Equipment QuantityAir-Circulating Oven 1

Claw Type Vacuum Pump 1

Intelligent Airtight Refrigeration Heating Cycle Device

2

High & Low-Temperature Pump 6

Glass Reaction Kettle100L * 250L * 2

Rotary Evaporator 50L * 4

Our Infrastructure

List of Major Equipment in Kilo Lab


Our Infrastructure

Analytical Equipment

QC Center

• LC/MS

• GC/MS

• UV-Spectrometer

• Optical rotation instrument

• HPLCs (Agilent 1260 and 1200)

• FTIR

• GC (Shimadzu)

• Melting point measuring apparatus

• Karl-Fisher-Titrator, etc.

• 400 MHz NMR (contract lab)


Our Infrastructure

Co-operational Production Base [Co-Investor]

- GMP certified &CFDA approved- Compliant to ISO 9001 requirements- More than 20 reactors from 50L to 5000L

Shanghai Qingsong Pharmaceuticals Co., Ltd


Resources & Core Team

Cooperation with well-known research institutes

Innovative and strong R&D, analytical and business team

Emphasis on environment, health and safety management (EHS)

Advanced project management process

Standard quality control system

IP protection



Work with Well-known Research InstitutesLong-term partnership with well-known research institutes, top universities, famous pharmaceutical companies, etc. Their database, advanced equipments, excellent professors are the powerful technical support of Rainbow Chemistry.


Technical Committee of Experts: Experts regularly come to Rainbow for guidance, solving the major problems and bring latest industry information.

• Prof. Meihua Xie, researcher at the Shanghai Institute of Pharmaceutical Industry, experienced in drug innovation and process research, successfully developed ACE inhibitor-Captopril, winning third prize of National Prize for Progress in Science and Technology .

• Dr. Shiliang Shi, researcher at Shanghai Institute of Organic Chemistry, graduated from Massachusetts Institute of Technology, recruited as talent of National "1000 Youth Talents Plan“, focusing on the research of chiral compounds and asymmetric synthesis.

• Prof. Ping Wang, researcher at East China University of Science and Technology, recruited as talent of National "1000 Youth Talents Plan“, professor of University of Minnesota, focusing on promoting the new molecular biological technology application in green chemical industry and environmental protection.


Scientific advisory team


• COO Ms. Jihong Liu, more than 20 years of management experience in pharmaceutical listed enterprise. Rich experience in drug GMP production, quality management, approval and certification. Mainly responsible for the main work of company management.

• R&D Director Dr. Tao Zhou, graduated from Shanghai Institute of Organic Chemistry, the main research direction is the total synthesis of natural products, published in a variety of internationally renowned magazines. More than 5 years experience in process R&D for API. Strong ability at making new compounds and process optimization.


Core Team


• Research group members all have advanced education background, more than half of them are doctors and masters.

• Managers and major research members all have at least 10 years working experience in international and domestic companies.

Our Core and Innovative Team


25-Jun-1821

EHS is as equally important as all other Rainbow business objectives. EHS manager reports to CEO directly.

Environment Friendly

• Risk management and evaluation on hazardous chemicals and related utilization.• Full-face mask, full suit, anti-chemical protective clothes, and so on are selected and provided to operators based on various reactions.• Annual health examination & employment injury insurance.

Health Caring

• All waste treatment is handled carefully and taken off-site by qualified disposal contractors.• Waste gas absorption system.

Safety Focusing• Smoke detector, fire alarm, fire hydrant, foam fire extinguishers and sprinkler system present in all rooms, emergency facilities present in all chemical handling areas.• Emergency medicine box and safety shower and eye washing machine.• High quality lab ventilation systems.

Shanghai Rainbow Chemistry Co., Ltd copyright



Strict product quotation evaluation system.

Arrange the project properly, keep tracking and coordinating in time.

All the documents of projects have both hard copies and electronic copies.

Project Management


25-Jun-18 23

Quality ManagementShanghai Rainbow Chemistry Co., Ltd & Shanghai Rainbow Meditech Co., Ltd's quality management system is based on GLP and has more than 200 SOP operating documents. The company successfully passed the customer's on-site quality audit. Relying on enhanced quality management system, we become a supplier of starting materials for pharmaceutical companies.

Raw material analysis Raw

material release

TIP

Review & Approval of

MBRDeviation Investigatio

n and Change

Management In

Production

Process Control

Product Analysis

Product release

Production report

Quality Management



SOPs of Kilo labProcedure for technology transfer of production project Procedure of change controlProcedure of deviation management

Procedure of audit

Management procedure of batch numberManagement procedure of outsourcing analysis sample numberManagement procedure of quality standardManagement procedure of lab notebookManagement procedure of corrective action & preventive action tracingManagement procedure of supplier evaluation and qualification

Management procedure of Master Batch Record (MBR)

Management procedure of Production Batch Record (PBR)

Management procedure of Batch Production Record (BPR)

Execution of Production Batch Record

Management procedure of original analysis data

OOS and other lab investigationsManagement procedure of sampling, sample keeping and keeping sample use

COA management procedure Management procedure of analysis standard sampleManagement procedure of label in analytical laboratoryManagement procedure of instruments in analytical laboratory

Management procedure of analysis record book

SOPs of QC

SOPs of QA

SOPs of Production

Material management procedure of kilo lab

Equipment cleaning operation procedure

Record of equipment cleaning

Regulations of safe production

SOP system:



IP Protection

Corporate practice: CDA in contract Password-protected report In CDA and service agreement, clients owns all data and IP

Company polices：Confidentiality agreement with employees SOPs in place for IP protection and notebooks

Strict information security regulations Frequent training programs

Infrastructure: Physical security including badge access Disabled duplication function on PCs Domain/proxy control on local computes;limited internet

access



Service ConceptThe Company Always Insists: Customer First, Service Is Supreme

Customer is the most precious resource, all the reasons for the existence of Rainbow.

Respect customers, understand customers, and continuously provide services and products beyond the expectation of customers are the concept that Rainbow has been adhering to and advocating.

In the eyes of customers, each of our employees represents the Rainbow. We know that 1% of our mistakes is 100% loss for customers. So we take every opportunity to cooperate with customers.

We always believe that the most important measure of success is the degree of our customers’ satisfactory.

Our AimS


Aims

Building Up GLP QC Center

Providing Innovation Platform for Global Customers

High Quality Products and Professional One-stop Services

Establishing High Standard GMP Production Base

Green Chemistry

Our AimS


Worldwide … distributing in Europe, North America, Asia, etc.

Our Customer


Many thanks !

Website: www.rainbow-chem.com E-mail: [email protected]

Tel: +86-21-64968086 　Fax: +86-21-64968087

Address:3rd floor, Building 7, 251 Faladi Road,

Zhangjiang Hi-Tech Park, Pudong District, Shanghai, P.R. China

Rainbow-chemTo create first-class R&D and production chain and to become gold supplier in chemical and pharmaceutical industry

Shanghai Rainbow Chemistry Co., Ltd

Rainbow-Chem · Customer Synthesis • Drug discovery & preclinical development support •...

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