BioDuro is a contract research organization founded in 2005 in San Diego that provides discovery, development and manufacturing services across multiple facilities in the US and China. It has grown to over 600 employees and offers capabilities across discovery, preclinical and clinical development, including medicinal chemistry, DMPK, formulation development, analytical testing and cGMP manufacturing. BioDuro values accountability, integrity, results, respect and tenacity in serving its clients.

1. Overview
San Diego USA Beijing China Nanjing China Shanghai China
Overview
BioDuro

2. History
Founded in San
Diego by Biotech
Investment Group
2005
2009
2010
2012
2013
2015
Grown to 600
employees in Beijing
and acquired by PPD
Recipient of Pfizer’s
2010 Difference
Maker Award
Formex joins Biotech
Investment Group,
operating in a 44,000
sq. ft. cGMP facility
92,000 sq. ft.
Shanghai facility
opened to meet
growing client
demand
BioDuro reacquired
from PPD, BioDuro
and Formex merge to
enable broad range
of service offering
Overview
BioDuro

3. Values
Accountability
We take responsibility for our
actions and behavior at all times,
and conduct ourselves to
established metrics of high
performance.
Integrity
We are honest with ourselves and
transparent in our actions, and hold
Intellectual Property (IP) standards
at the highest level.
Results
We establish clear measures of
success, and deliver results to our
internal and external stakeholders.
Respect
We deeply Respect our employees
and clients, within a Family
structure, based on Equality
and Understanding.
Tenacity
We know we may face adversity,
but will never give up,
but persevere to succeed.
Overview
BioDuro

4. BioDuro Solutions
Discovery Development
Chemistry
DMPK
Biology
Pharmacology
Formulation
cGMP Manufacturing
Analytical
Overview
BioDuro

5. San Diego USA
Corporate headquarters.
Home to development and
manufacturing operations.
Size: 44,000 sq. ft.
Featured Capabilities: Tableting,
Coating, Hot Melt Extrusion,
Spray Dried Dispersion
Beijing China
Supporting discovery operations
with 300 regular fume hoods and
18 scale up hoods since 2006.
Size: 100,000 sq. ft.
Featured Capabilities: Monoclonal
Antibody Discovery,
Synthetic Chemistry
Shanghai China
Growing facility for DMPK
and Bioanalysis work,
with an 18,000 sq. ft. Vivarium
Size: 92,000 sq. ft.
Featured Capabilities: In vitro
ADME, In Vivo PK
Facilities
Overview
BioDuro

6. 10 Years
Maintaining great working
relationships with our
clients since 2005
20 compounds
A track record of 20
compounds successfully
delivered to the clinic
100% success rate
A flawless record of
successful cGMP
manufacturing campaigns
conducted in 2015
1:4 PhD to Non-PhD
An industry leading staff
ratio to support quality
science.
10-100 fold solubility enhancement
Formulation development expertise
that guarantees significant solubility results
The Proof is in the Data
Overview
BioDuro

7. Medicinal
Hit selection
Hit to lead chemistry
Multiple-parameter lead
optimization to Target
Product Profile
Patent preparation and filing
Chemistry
Synthetic
Organic synthesis
Bioorganic synthesis
Process discovery &
development
Parallel chemistry
Scale-up to non-GMP drug
substance
Analytical
Method development
Routine purification
Chiral separation
Impurity analysis
Thermal analysis
Particle size, shape
and crystallinity
determination
Computational
Small molecule modeling
Conformational analysis
ADME and physiochemical
property prediction
Homology modeling
Library design, enumeration and
diversity analysis
Strong operational support for material
sourcing and compound management
Reproducible high-quality data
State-of-the-art equipment
Advantages
Responsive project management
Broad therapeutic desease area expertise
Overview
BioDuro

8. Services
Reagent generation and characterization
Assay development
Compound/Peptide/Antibody screening and profiling
Biomarker research
Custom monoclonal antibody generation
Target validation
Biology
Capabilities
Enzymatic assays
GPCR membrane prep binding assays
Epigenetics targeted assays
Cell-based assays
Ion channel assays
Molecular biology based assays
Protein based assays
Multiple assay detection formats
ELISA
Real-Tme PCR
QC of DNA, RNA and protein
IHC/IF/FISH
FlowCyto & RIA
Overview
BioDuro

9. In vitro ADME
Physiochemical properties
In vitro drug metabolism
Permeability measurement
Drug-Drug Interaction
DMPK
In vivo PK
Tissue distribution studies
Metabolite identification and quantification
Formulation development
Integration with drug discovery
and drug development teams
5-10 day project turnaround time
Custom studies for ADME AAALAC
accredited animal facilities GLP-like
laboratory environment Dedication to
animal welfare
The BioDuro Advantage
In-life dosing and sampling
Bioanalytical method development
Bioanalysis
Overview
BioDuro

10. Pharmacology
Services
Translational research
Biomarker discovery & development
Compound efficacy validation
Consultation
Therapeutic Focus
Oncology
CNS
Inflammation and Immunology
Metabolic Diseases
Overview
BioDuro

11. Pre-formulation
A critical mass of pre-formulation capabilities across BioDuro facilities:
Aqueous solubility
(neutral, pH dependent)
Thermal analysis
Particle size
Polymer miscibility
Elucidate candidate attributes to help predict
the best formulation approach
Physical, chemical and biological characterization
Solvent/Oil solubility
Partitioning (logP, logD)
Permeability measurement (Caco-2, PAMPA)
Excipient compatibility
Overview
BioDuro

12. Formulation Development
Solution Engine
for Formulation Challenges
Drug and target characteristics
drive development choices
Generate and select acceptable
dosage forms that maximizes drug
concentration at target
Improve solubility, permeability,
delivery as needed
Running off a customizable
solutions platform that develops
innovative and pragmatic solutions
Overview
BioDuro

13. Analytical Chemistry
Collaboration in the product development process with BioDuro’s
team and the clients
Method development and in
process testing guided by industry
experts
Seamless transfer of robust,
phase-appropriate validated
methods
ICH compliant stability monitoring
to ensure product quality
Scientifically sound methods
developed to align with
formulation properties
Flexible teams to perform stand-
alone and integrated projects
Overview
BioDuro

14. cGMP Manufacturing
Dosage Forms
Tablets
Capsules
Beads, Pellets, and Granules
Oral liquids
Topicals
API in a capsule (Xcelodose®)
Target validation
Process Technologies
Hot Melt Extrusion
Spray Dried Dispersion
Roller Compaction
Pan Coating and Wurster Coating
Granulation (wet, dry, high shear)
Fluid Bed Drying
Milling, Blending, Compression,
Encapsulation
Comprehensive solutions for clinical trial material
preparation in support of clinical trials up to phase III
Overview
BioDuro

15. Experienced and Client Focused
Broad range of scientific backgrounds
Scientists as project leads providingreal Tme updates
Effectively use project management system and tools
Adherence to top scientific and strict quality standards
Effective collaboration and teamwork across departments
Responsive and flexible to meet client needs
Our team
Overview
BioDuro

16. San Diego USA Beijing China Nanjing China Shanghai China
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