SoliPharma LLC is a pharmaceutical contract research organization specializing in solid drug development, pre-formulation, formulation, and commercialization services. Based in Delaware with major labs in Hangzhou BioHub, China, it provides analytical testing, solid form studies, crystallization development, formulation development, and other services to pharmaceutical and biotech clients globally. SoliPharma aims to ensure high quality research and potential intellectual property value for its clients.
1. 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.
1
TESTING
CNAS L6384
2. 2
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.
3. Analytical Testing
Pre-formulation
Solid Form Studies
Crystallization Development
Formulation Development
Development Packages
Instrumental Capacity
Drug Development Partnership
3
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.
4. Analytical TestingPhysicalCharacterization
• 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
QuantitativeTestingandMethodDevelopment
• HPLC Method
Development
and Validation
• Drug
Substance
Crystal Form
Impurity
Analysis
• Drug
Substance
Crystal Form
Analysis in
Drug Product
StructuralElucidation
• NMR
Spectroscopy
• Single Crystal X-
ray Structure
Determination
• IR Spectroscopy
• Mass
Spectroscopy
4
5. 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
5
6. 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
6
8. 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
8
9. 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
9
13. Hangzhou Bio-pharm Park
13
• 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.
14. Hangzhou Bio-pharm Park
14
• 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.
15. 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
15
TESTING
CNAS L6384
