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Shanghai Caerulum Pharma Discovery 1 Tel021-69018966 websitewww.caerulumpharma.com email : [email protected]

Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

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Page 1: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Shanghai Caerulum Pharma Discovery

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Tel:021-69018966 website:www.caerulumpharma.com email : [email protected]

Page 2: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Content

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About Us

Chemical Services

Biological Services

Page 3: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

About Us

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Page 4: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

About Us

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From the humble set up of one laboratory in 2012, Caerulum now consists of 5 standard laboratories and 2 pilot laboratories focused on chemical compound production, one DMPK lab and one analysis room occupying a space of over

1000m2 located within a beautifully landscaped innovative compound just 30km from the city center of Shanghai.

Page 5: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

About UsOur Labs

5 Standard 2 Pilot 1 Analysis 1 DMPK Biology Site (Sichuan Chengdu)

Our Team

1 PhD in Chemistry 2 PhD in Biology 15 Chemists 2 Bioanalysts 5 Customer Service 2 QA/QC 2 Finance 2 HR & Administration

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Page 6: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Shuowen Wang (王硕文)Deputy General Manager

Dr. Qixian Lin (林其先)Head of Chemistry• Group Leader, Medicinal Chemistry, Hisun Pharmaceutical• Postdoctoral Research Associate, Medicinal Chemistry, Dartmouth College, New Hampshire, USA

Dr. Jianyu Liu (刘建余)Head of Biology• Department Manager, New Drug Screening, Haisco Pharmaceutical• Postdoctoral Research Associate, Markey Cancer Center, University of Kentucky, USA

Kyna Chan(陈克燕)General Manager

Dr. Aishen Gong (宫爱申)Head of DMPK• Department Manager, Biological Evaluation, Haisco Pharmaceutical• Group Leader, DMPK &Toxicology, Shanghai Hengrui Medicine

Page 7: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Organization Chart

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General Manager

CRO

Project

Department

FTE

Custom Synthesis

Pharmacology

DMPK

Biological Screening

Toxicology

Quality

Assurance

Quality Control

Account

Department

Cost control

Customer

Service

Quotation

Promotion

Information

Operation

Department

HR

Operation Safety

Procurement

Page 8: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Our services

Chemical Services FTE Project Custom Synthesis Compound Supply

Biological Services•DMPK•Biological

screening•Toxicology

Our Services

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Page 9: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Chemical Services

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Page 10: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Dedicated technical team and equipment

Strict SOP for safe production and quality assurance

Detailed weekly report and original data for new drug application

Real-time CCTV system

Strict confidentiality

Customized Services

1010

Page 11: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Standard Laboratory

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Page 12: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Pilot Laboratory

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Page 13: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

In House QC Equipments

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Page 14: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Storage

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Clockwise from the left: 1) Stocks cabinet, 2) Solvent cabinet, 3) Special reagents

Page 15: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

List of Equipments

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Equipment ListSerial number Name Size/Model Quantity

1 Reactor100L 550L 2

2 Multifunctional Reactor 50L 1

3 Rotary Evaporator20L 61L 3

4 Low temperature circulation Pump

DLSB-5L/20℃ 1DLSB-5L/-25℃ 1DLSB-10L/-25℃ 8DLSB-20L/30℃ 1DLSB-30L/-30℃ 1DLSB-30L/-30℃ 1DLSB-50L/-40℃ 1DLSB-30L/-40℃ 4

5 High temperature circulation PumpGSC-30 2

50L/200℃ 2

6 High and low temperature circulating pumpGDX-100L/-40℃ 3GDX-50L/-40℃ 1

7 Oil Pump8L 14L 42L 1

Page 16: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Production Regulation

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Pre-process

•Starting material•Equipments•Environment

In process

•In process control•Record keeping•Waste control

Final product

•Quality assurance•Warehouse &

delivery (labeling and packing etc.)

Note: Follows strict SOP for handling starting material to final product16

Page 17: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Weekly & Batch Reports

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Page 18: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Our Achievements

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1 FTE client for 2 years: > 150 projects, 15-20 chemists

Over 10 projects:From optimization to scale-up

mg → g → kg → >10kg →>100kg

Involved in discovery of 2 positive candidates that successfully enter

into IND & Phase II

Page 19: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Biological Services

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Page 20: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

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Established in 2017

Specific functional areas:

Sample reception and storageBiological sample storageSample pre-treatment

Instrument and equipmentDocument management

DMPK platform

Page 21: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

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DMPK Services

Specialized preclinical services for industrial and R&D facilities• Bioanalysis

• Method development/ validation• Quantitative analysis of various biological samples

• In vitro ADME• Metabolic stability• CYPs inhibition• Plasma & tissue protein binding• Solution & plasma stability• Metabolic profiling and species comparison (in construction)

• In vivo ADME• Quick PK screening in various species• Tissue distribution• Excretion• CSF sampling and BBB penetration

• Characteristic services• Technical support for preclinical development, project management and INDs

Page 22: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Biological Screening & Toxicology– Xpiscoric Inc, Chengdu

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State-of-the-art laboratories

• Molecular & cellular, LC/MS/MS labs• SPF animal facilities function as candidate

compound screening• Capability of PK/PD evaluation in large animals

such as beagle dogs, mini pigs and monkeys

Services offered:

• Technical and consulting services for biological screening

• PD/PK, pharmacology and safety of new drug R&D• Non-GLP safety evaluations

Page 23: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Our Superiority

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• Extensive experience in drug discovery and development

• Professional support for R&D strategy and project management

• Flexible and effective operation pattern

• Personalized service for customer

• Capacity to provide chemistry- PD- PK- toxicology integrated services

Page 24: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Key Clients

Page 25: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Our vibrant and dedicated team is here to serve you better!

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Page 26: Shanghai Caerulum Pharma Discovery · Final product •Quality assurance •Warehouse & delivery (labeling and packing etc.) ... • Excretion • CSF sampling and BBB penetration

Thanks for your attention

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