SoliPharma LLC

• Pharmaceutical contract research organization.

• Specializes in solid drug development, pre-

formulation and formulation, commercialization

enabling technology.

• Incorporated in Delaware, US, with major lab

spaces in Hangzhou BioHub in China.

• ISO/IEC 17025:2005 accredited for testing and

calibration.

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SoliPharma Introduction

• Solipharma LLC, founded in 2010, is the first Chinese pharmaceutical

CRO focusing on solid state technology in drug development and

commercialization enabling research.

• Capabilities cover polymorph / salt form screening; form research and

crystallization process development; pre-formulation assessments; solid

dosage form strategy and process development.

• Talents include world-class experts and award-winning drug development

/ regulatory scientists. Ownership / access to state-of-art instruments

and facilities in one of the largest technology incubators in China.

Analytical Testing Pre-formulation Solid Form Studies Crystallization Development

Formulation Development Development Packages Instrumental Capacity Drug Development Partnership

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SoliPharma Services

SoliPharma LLC ensures delivery of the highest quality research services on solid drug development, transparent reporting communication and potential IP value for pharmaceutical / biotechnology clients worldwide.

Analytical Testing P

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• Phase Analysis: XRD, Raman, IR

• Thermal Analysis: DSC, TGA, Hot Stage microscopy, Variable Temperature XRD

• Spectroscopy Analysis: Raman, IR, UV

• Bulk Analysis: Particle Size Distribution, Water Content, Moisture Sorption, Density

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• HPLC Method Development and Validation

• Drug Substance Crystal Form Impurity Analysis

• Drug Substance Crystal Form Analysis in Drug Product

Stru

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• NMR Spectroscopy

• Single Crystal X-ray Structure Determination

• IR Spectroscopy

• Mass Spectroscopy

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Solid Form Studies

Customized screening package for different development stage

Salt Screening and Stability

Polymorph Screening and Thermodynamic Stability

Cocrystal Screening and Stability

Identify the most preferred solid form for development

Solid Dispersion Screening

Draft technique disclosure document for patent application

Patent Application Drafting

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Crystallization Development

HPLC method

development and

validation

Solvent screening

Solubility profile

Metastable zone analysis

Design space for critical

process parameters

Product characterization

and analysis

SOP for unit operations

Tech Package

Control drug substance

crystal form

Achieve target Impurity

profile

Recovery yield from the

mother liquor

Optimize bulk property

Improve process output

Process Development

Develop new

manufacturing

process to meet

target product

profile and IP

strategy

Optimize process

to meet target

product profile and

minimize cost

Strategic Goal

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Pre-Formulation

Pre-formulation

• pKa, logP, logD determination

• Equilibrium and pH dependent solubility

• Solid and solution stability

• Dissolution

• Powder; Intrinsic

• Excipient compatibility

Physical Characterization

• Powder diffraction

• Thermal property

• Hygroscopicity / Water content

• IR/Raman spectroscopy

• UV spectrum

• Particle size distribution

• Microscopy

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Preclinical formulation development and CTD dossier

Commercial formulation process development and CTD dossier

Process Development Goal

F2 value great than 60 as compared to reference

Compliant with Pharmacopeia; Draft CTD dossier

Tech Package for Formulation Development

HPLC method development and validation / Drug substance and reference drug product characterization and analysis / Dissolution method development

Excipient compatibility / stability

Packaging compatibility

Design space for critical process parameters / SOP for unit operations

Formulation Development

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Development Service Package

Drug Substance

• Structure Elucidation

• Analytical Method Development

and Validation

• General Properties

• Synthetic Process Development*

• Impurity Profile Studies*

• Polymorph Studies

• Stability Studies

• Specification Justification

• CTD Dossier

• * Completed by partner company

Drug Product

• Characterization of API and

excipients

• Analytical Method Development

and Validation

• Excipient Compatibility Study

• Formulation Process

Development

• Packaging Compatibility Study

• Stability Studies

• Specification Justification

• CTD Dossier

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Characterization Instrument 1

X-ray Diffractometer Dynamic Vapor Sorption Polarized Light Microscope

Raman Microscope FT-IR Spectrometer pH Titrator

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Characterization Instrument 2

Thermogravimetric Differential Scanning Ion Chromatography

. Analyzer Calorimeter

High-performance Particle Size Analyzer Dissolution

Liquid Chromatography Apparatus

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Characterization Instrument 3

Friability Tester Disintegration Tester Clarity Testing Apparatus

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BioHub Labs Bruker 500 MHz NMR (BioHub)

Hangzhou Bio-pharm Park

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• http://www.hangzhoubio.com/index_en.php?mod=indexs

• Hangzhou Economic & Technological Development Area ("HEDA") was ratified by the State Council as a national-grade development zone in April 1993, and exercises jurisdiction over an area of 104.7 km2. Currently 34 km2 of that has been equipped with complete infrastructure, beautiful environment, convenient supporting facilities and efficient government services.

• HEDA, a sub-center of Hangzhou Municipal City("Xiasha New Town"), is the ONLY national development area which collectively possesses industry base, export processing zone, university town and riverside residence area, etc.

Hangzhou Bio-pharm Park

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• Bio-pharm industry is one of the four dominant industries within HEDA. The New Medicine Harbor has gathered a large number of well-known enterprises, and formed a distinctive industry cluster.

• The BASE has over 60 companies in 4 big sub-industries: biological medicine, new medical devices, modern Chinese medicines and new chemical substances.

• Rich technological and educational resources in the biggest provincial university town: 6 well known universities with world class programs in biological and pharmaceutical related sciences.

• Five public service platforms: Public Experimental Center Platform; Drug Crystal Formation R&D Platform; Bio-Tech Drugs Pilot Scale R&D Platform and etc.

• Policies of speeding up the development of bio-pharm industry in HEDA have launched, include "Acceleration Plan of the Development of Bio-Pharmaceutical Industry in HEDA".

• The Base has facilitated venture capital companies to work with HEDA. A "Bio-pharm Industry development fund" of RMB 200 Million has been set up for the first phase.

SoliPharma LLC

For inquiries, questions and consultation,

please contact:

VP of International Strategy / SoliPharma LLC.

Phone: 919-386-9384 (Office)

Email: solipharma.us@gmail.com

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