Embedded in everything we do at BioDuro is the reality that the product we help create has the potential to cure patients

1. BioDuro Capabilities
Presentation
Overview
BioDuro
San Diego USA Beijing China Shanghai China

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. Overview
BioDuro
Vision: Speed development and delivery of better drugs, because PATIENTS are waiting
Mission: To be the BEST, world class drug discovery, development, and manufacturing integrated partner
of choice
Accountability
We take responsibility for our actions
and behavior at all times, and conduct
ourselves to established metrics of
high performance.
Vision, Mission, and Corporate Values
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.
Integrity
We are honest with ourselves and
transparent in our actions, and hold
Intellectual Property (IP) standards at
the highest level.
Tenacity
We know we may face adversity, but
will never give up, but persevere to
succeed.

4. Overview
BioDuro
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
Center for Integrated Drug Discovery, with
turnkey approach to medicinal chemistry,
discovery biology, and DMPK
Size: 92,000 sq. ft.,18,000 sq. ft. Vivarium
Featured Capabilities: In Vitro ADME, In Vivo
PK
Facilities

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

6. Overview
BioDuro
BioDuro Discovery and Development Continuum
of Services
Early
Lead
Lead
Series PDC IND NDA
Target
Identification
Target
Validation
Lead
Identification
Lead
Optimization
Preclinical
Development
First In
Man
Phase
1
Phase
2 a/b
Phase
3
Approval
▪ Feasibility Evaluation
▪ Assay Development
▪ Reference Compounds
▪ Library Design
▪ De novo Design
▪ Virtual Screen
▪ Hit Triage
▪ Hit-to-Lead
▪ Lead Optimization
▪ Medicinal Chemistry
▪ Assay Development
▪ Pre-Clinical Formulation
▪ ADME/DMPK
▪ API Development
▪ Human Dose Prediction
▪ In-vivo PK (dog, monkey)
▪ Non-GLP Tox Studies
▪ Pre-Formulation
▪ API cGMP manufacturing
▪ Formulation Development
▪ Formulation Optimization
▪ cGMP CTM Manufacturing
▪ Analytical Method Dev/Valid
▪ Release and Stability Testing
GLP Toxicology and API cGMP manufacturing outsourced to partners.

7. 12 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 superior record of
successful cGMP
manufacturing campaigns
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

8. Overview
BioDuro
Discovery Chemistry

9. 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 physicochemical
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
The BioDuro
Advantage
Overview
BioDuro
• Responsive project management
• Broad therapeutic area expertise

10. Overview
BioDuro
Why Work With BioDuro?
People
- 350+ experienced, well-educated scientists
- 15% PhD; 50% MS; 35% BS
- On average >6 years work experience
- Excellent problem-solving skills
- Frequent, clear and transparent
communication
- Focus on delivering quality products, data
and support
Infrastructure
- Excellent infrastructure
support enables scientists
to focus on chemistry
Systems
- Effective and efficient
systems ensure smooth
logistics from project
start to finish

11. Overview
BioDuro
Our People
Group Leaders
• Typically PhD chemists with many years experience (>7 years on
average)
• Most group leaders have been with BioDuro for more than 6 years
• Lead day-to-day lab operations on their projects; design and
troubleshoot routes
• Excellent chemistry, project management and communication skills
• Almost daily interaction with clients as key point of contact
• Supervise and train ~10-20 bench chemists
Directors
• Seasoned scientists with ~10-25 years working experience
• Responsible for 3-4 clients; 4-5 group leaders; ~60 bench
chemists
• Provide scientific and managerial oversight
• Lead MedChem and Integrated projects
• Communicate directly with clients to ensure satisfaction
• Coach group leaders to become more effective leaders and
communicators
Bench Chemists
• High number of experienced chemists with many years of service
• BS - average 7 years of experience
• MS - average 5 years of experience
• PhD – average 4 years of experience

12. Overview
BioDuro
- Easy access to essential equipment in the labs
- CombiFlash or Biotage (1 per 15 chemists)
- Microwave (1 per 30 chemists)
- Prep-HPLC
- Every chemist has access to SciFinder
- Literature requests are fulfilled in less than 24 hours
- Quick turn-around times for critical services
- LC-MS – 30 min
- H-NMR – 1 h
- Prep-HPLC – 1-2 d (depends on scale)
- SFC – 1-2 d (depends on scale)
Our LabsWell-equipped modern labs in Beijing and Shanghai
(500 fume hoods)

13. Overview
BioDuro
- Provides both analysis and purification support for all projects
- Method development
- Maintain instruments
- Open-access systems, train chemists
- Purification including chiral separation
- 12 x LC-MS (Agilent, Shimadzu)
- 22 x HPLC/UPLC (Agilent, Shimadzu, Waters)
- 6 HPLC/UPLC for purity determination
- 6 HPLC for method development
- 6 prep-HPLC purification systems (3 MS-triggered)
- 2 large scale prep HPLC systems – up to 10 g/day/instrument
- 2 chiral HPLC - 0.5-2 g/day
- 2 x SFC (Thar): Analytical X5 & Prep-80 – 1-5 g/day
- GC-MS (Shimadzu)
- 4 x NMR (2 Varian, 2 Bruker)
Analytical Chemistry & Purification

14. Overview
BioDuro
Services Key Equipment
• Scale up services (up to 5 kg)
• Synthesis of intermediates, building blocks,
references, metabolites, impurities
• Synthesis of non-GMP tox and clinical materials
• Process Discovery and Development
• Optimization of reaction conditions
• Route discovery, selection and development
• Development of robust and scalable route
• Pilot Production and Manufacturing (with Partners)
• Synthesis of non-GMP intermediates and API
• 20 hoods including 8 large walk-in rooms and
5 large walk-in hoods
• 2L - 100L Reactors
• 50L Separatory flasks
• 20L Evaporators
• DSC (TA, Q20)
• Drying ovens
Scale-up Chemistry

15. Overview
BioDuro
Discovery Biology

16. Services
Reagent generation and characterization
Assay development
Compound/Peptide/Antibody screening and profiling
Biomarker research
Custom monoclonal antibody generation
Target validation
Discovery 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

17. Assay Platforms
Assay detection formats: FP, TR-FRET, HTRF, LANCE, filter binding, SPA
and other radiometric assays, luminescence, AlphaScreen, LC/MS, FLIPR,
ELISA, patch clamp, surface plasmon resonance based label-free analysis
and FACS
Equipment
Plate readers and assay detection instruments: EnVision, Enspire,
SpectraMax, FLIPR tetra, Flexstation, MSD, TopCount, ABI Tagman, SPR-2,
Accuri C6 Flowcytometer, Patchliner etc.
Liquid dispensers: Multidrop Combi nL Dispenser, Matrix PlateMate, Agilent
Bravo Automated Workstation
Other standard and essential drug discovery research lab equipment for
conducting molecular and cellular biology works

18. Overview
BioDuro
Services
Cloning and Expression
Antibody Purification
Immunoassay
Antibody Capabilities
Capabilities
Antibody cloning and expression
• E. Coli
• Mammalian cells
Immunoassays/cell based assays
• ELISA assay
• Antibody-dependent Cell Mediated Cytotoxicity (ADCC) Assay
• Complement Dependent Cytotoxicity (CDC) Assay (LDH release)
Overview
BioDuro

19. Overview
BioDuro
Drug Metabolism and Pharmacokinetics (DMPK)

20. Overview
BioDuro
Our Team Our Leadership Our Quality
Overview
Our well established team
consists of scientists skilled in
the following areas:
▪ Bioanalysis
▪ In vitro ADME
▪ In vivo PK
▪ Vivarium Management
A group of respected experts
in drug discovery and
development with an average
of 8-15 years experience
working at CROs and
Universities.
Committed to highest
standards of quality and to
exceeding customers
expectations.
All client reports undergo
quality control by group
leaders and quality will be
assured by study directors.

21. Overview
BioDuro
Services
In Vitro ADME
• Physicochemical properties
• In vitro drug metabolism
• Permeability measurement
• Drug-Drug Interaction
In Vivo PK
• Tissue distribution studies
• Metabolite identification and quantification
• Formulation development
• In-life dosing and sampling
• Bioanalytical method development; bioanalysis
DMPK
Capabilities
PO, IV, SC, IP, IN; IV/PO cassette
dosing
Multiple dosage routes
Multiple cannulation models
Liver microsome/hepatocyte stability
CYP phenotyping
Metabolite ID (phase I and II)
Caco-2
PAMPA
CYP inhibition assay
Time dependent inhibition
GSH trapping assay
Overview
BioDuro

22. Overview
BioDuro
In vitro ADME Bioanalysis
Capabilities
- Physicochemical properties
- logD
- Solubility
- Permeability (PAMPA , Caco-2)
- In vitro drug metabolism
- Stability in microsomes,
hepatocytes, solution, plasma,
blood, etc.
- Metabolite Profiling and
Identification (Phase I and
Phase II)
- Drug-Drug Interaction Profiling
- Cyp phenotyping
- Cyp inh. / time-dependent inh.
- Plasma and Tissue Protein
Binding
- Bioanalytical method
development; bioanalysis
- HPLC or LC-MS/MS for
Small Molecule
- LC-MS/MS for
peptide/protein
- ELISA for
protein/antibody, ADC
Others
- PK/PD Studies
(Oncology and
metabolic disease)
- In Vivo/In Vitro
Correlation Analysis
- IND-enabling Studies
for CFDA
In vivo PK
- Rodent PK
- Rodent Tissue Distribution
- Dog/Monkey PK
- Exploratory Safety in
Rodent/Dog/Monkey
- Metabolite identification and
quantification
- Formulation development
- In-life dosing and sampling
- PO, IV, SC, IP, IN;
- IV/PO cassette dosing
- Multiple dosage routes
- Multiple cannulation models

23. Overview
BioDuro
Equipment and Facilities
The BioDuro Advantage
Vivarium
AAALAC accredited vivarium (1,500 sq. m) for rodent
PK/tissue distribution and dog PK studies
Small animal room (rodents): SPF; Dog animal room:
conventional
Internal Institutional Animal Care and Use Committee (IACUC)
-internal and external experts
Review SOPs; Review and approve protocol; Monitor animal
use and welfare
Instruments
Total of 8 LC-MS/MS systems
2 API-5500; API-4000Qtrap; API-4500Qtrap and 4 API-
4000; Typical LOQ: 1 nM or lower
2 UPLCs - Shimadzu LC-30AD and Waters H-class
We take great pride in adhering to strict
regulatory standards and work in a
professional GLP like environment.
We maintain a high quality AAALAC
accredited vivarium and run our studies on
quality controlled instruments.
BioDuro is strongly committed to ensuring
the welfare of animals used in our research.
We treat the animals we use humanely, and
adhere to strict standards of care and ethical
principles in providing for their welfare.

24. Overview
BioDuro
Pharmacology

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

26. Overview
BioDuro
Animal Models for Metabolic Disease
- High fat diet induced obese (DIO) rats/mice
- Streptozotocin (STZ) induced type 1
diabetic rats/mice
- High fat diet (HFD) + STZ induced type 2
diabetic rats/mice
- KKAy mice with NASH, retinopathy,
nephropathy
- ob/ob and db/db mice
- GK (Goto-Kakizaki ) rats
- ApoE KO mice
- Myocardial infarction and reperfusion injury
in rats/mice
- Renal ischemia and reperfusion injury in
rats/mice

27. Overview
BioDuro
Animal Models for Immunology and Inflammation
Cytotoxic T cell (CD8+)
Helper T cell (CD4+)
Reg/Supp T cell (CD4+ CD25+)
Memory T cell
Deposition of Immuno-complex
Cytokines secretion
Eosinophil apoptosis
IgE production
Immune suppressor
T-Cell as Target B-Cell as Target Cytokines as Target Others
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Type I Diabetes
- Experimental Autoimmune
Encephalomyelitis
- Inflammatory Bowel Disease
- Atopic Dermatitis
- Psoriasis
- Type IV hypersensitivity
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Type I Diabetes
- Experimental Autoimmune
Encephalomyelitis
- Inflammatory Bowel Disease
In vivo Models:
- Rheumatoid Arthritis
- Inflammatory Bowel Disease
- Psoriasis
- Asthma
- Type IV hypersensitivity
TNFα;
IL-1;
IL-17; IL-17R
IL-6; IL-6R;
IL-12/23;
Memory B cell
Follicular B cell
Marginal Zone B cell
Reg/Supp B cell
Deposition of Immuno-complex
Plasma Blast
Plasma Cell INFγ; IL-4
IL-12; IL-2 Histamine receptor
mTOR
- LPS Induced Cytokine Secretion
- Concanavalin Induced Cytokine
Secretion
- Asthma
- Atopic Dermatitis
- Rheumatoid Arthritis

28. Overview
BioDuro
Multiple Sclerosis Intestinal Bowel
Disease
Rheumatoid Arthritis
Animal Models for Immunology and Inflammation
- MBP-induced
EAE in Lewis
rats
- PLP-induced
EAE in SJL/J
mice
- MOG35-55
induced EAE in
C57BL/6 mice
- DSS-induced
colitis in
C57BL/6 mice
- DSS-induced
colitis in rat
- Collagen-Induced
arthritis (CIA) in
DBA/1 mice
- Collagen-induced
arthritis (CIA) in
Lewis rats
- Adjuvant-Induced
arthritis（AIA）in
Lewis rats
- G6PI-induced
arthritis in DBA/1
Mice
Asthma
- OVA-induced
asthma in mice

29. Overview
BioDuro
Systemic lupus Erythematosus (SLE)
- Pristane-induced lupus in mice
- MRL/lpr mice
Animal Models for Immunology and Inflammation
Delayed Type Hypersensitivity (DTH)
- Oxazolone-induced DTH in mice
Psoriatic Model
- Imiquimod-induced psoriasis in mice
FITC Induced Dermatitis
- FITC-induced dermatitis in mice
LPS-induced Acute Inflammation
- LPS-induced cytokine secretion in mice
- LPS-induced acute lung inflammation in
BALB/c mice
Concanavalin A-Induced Cytokine Secretion
- Concanavalin A - induced cytokine
production in Lewis rats and mice
The BioDuro
Advantage
Extensive drug discovery and development experience
enabling support of fully integrated programs, including
study design and data interpretation. Special expertise in
metabolic and inflammatory diseases is coupled with a
commitment to working with clients to develop
customized models for rare diseases.

30. Overview
BioDuro
Formalin Induced
Nociceptive Models
Ischemia-reperfusion Model
of Acute Kidney Injury
Citric Acid Induced
Cough Model
Other Disease Animal Models Available
- In mice
- In rats
- In mice - In Guinea pigs
Cisplatin Induced
Acute Kidney Injury
- In mice

31. Overview
BioDuro
Oncology

32. Overview
BioDuro
Services
Oncology therapeutic target discovery and validation
Compound and biologics efficacy and early safety
evaluation
Consultation
Oncology drug discovery
Oncology
Capabilities
Cellular model based assays
• 2D culture, 3D spheroid culture, hTME-3DX Screen and Verify™
Cancer animal models
• CDX
• PDX
Immuno-oncology
• Syngeneic mouse model
• Humanized immunity system model
Overview
BioDuro

33. Overview
BioDuro
In Vivo Models
- CDX: Cancer cell line
derived xenograft
models (>220 lines and
64 validated models)
- PDX: Patient-derived
xenograft models
- Syngeneic mouse
tumor models (for
cancer immunotherapy)
- Subcutaneous tumor
models
- Orthotopic tumor
models (breast, liver
and lung cancer)
- Experimental
metastatic tumor
models
- Systemic leukemia,
lymphoma and multiple
myeloma models
- Tumor growth
inhibition (TV, TW,
Luciferase based in
vivo imaging)
- Tumor growth delay
- General toxicity (BW,
animal behavior
observation)
- PK/PD, Histology,
Down-stream signaling
(qRT-PCR, Western
blot, FACS)

34. Overview
BioDuro
In Vitro Assays
- Drug target
expression: RT-PCR,
Western Blot, IHC,
FACS
- Drug target validation:
Gene over-expression
and knockdown
Drug efficacy evaluation
- Enzyme activity：
ELISA, Biochemistry
assay
- 2D and 3D culture
(hTME-3DX Screen
and Verify™, Low
adherence/spheroid)
- Cell proliferation：
MTS, CTG, BrdU
- Cell-based assays：
Apoptosis, Migration
& invasion
- Histology staining:
Paraffin blocks
preparation, H&E, IHC

35. Overview
BioDuro
Advanced Models for Human Cancer:
hTME-3DX Screen and Verify™
hTME-3DX
Screen and
Verify
Patient-Derived
Xenograft (PDX)
PDX Surrogacy, In vitro - In
vivo Companion, Fine Tuning
MoA and Pharmacology
Greatest Patient Diversity, Lower Autocrine
Bias, Higher Throughput, Time & Cost
Savings
• Human Tumor Cells
• Murine ECM (Human TME
Alignment)
• Humanized TME
• Human Tumor Cells
• Murine ECM
• Murine TME
Better Patient Diversity (vs. CDX),
PK/PD Studies, Broader MoA

36. Overview
BioDuro
Advanced Modeling for Human Cancer:
High Take-rate in Humanized TME
*Molecular Response, LLC 2016; ✝Siolas & Hannon 2013 Cancer Res;✧Dangles-
Marie, et al. 2007 Cancer Res and Gillet, et al. 2013 JNCI
Patient 3DX-TGA PDX; CDX Cell Culture
CRC
Breast
Ovarian
GI
Lung
CNS
HCC Panc
Bladder
> 95%* 23-75%✝ 10-50%✧
Loss of paracrine
dependent tumors
Selection bias to
autocrine tumors
Murine TMEHumanized TME Limited TME
Humanized Tumor
Microenvironment
TumorMicroenvironment(TME)
Superior Pharmacogenomics (PGx)

37. Overview
BioDuro
Drug Screening in humanized 3D Culture:
300+ Validated Models
• 305 Characterized Models
• 15 Tumor Indications
CRC
Breast
Ovarian
GI
Lung
Cervical
Melanoma
Panc
RCC
Prostate
3DX Models
Meso
CRC, 20
Breast, 25
Melanoma, 20 Pancreatic, 25
Renal Cell, 26
Cervical, liver,
stomach, etc., 88
NSCLC, 25Bladder, 24
SCLC, 31
Breast, 25
Ovarian, 20
Non
Metastatic
48%
Metastatic
52%
PRIOR RX & METASTATIC MODELS
Drug naïve
43%
Prior Rx
57%
*SQHN (6), Liver (10), Mesothelioma (25), Stomach (25), Cervical (13)

38. Overview
BioDuro
Immuno-oncology
- PBMC, B, T and NK cell
isolation
- T and NK cell activation
and proliferation
- Immune-phenotyping
with multi-color FACS
- Immunocytes and
cytokine infiltration
assay in 3D tumor cell
spheroids
- Multiplex cytokine
analysis, MSD
- PBMC or NK cell
mediated toxicity
- Antibody dependent
cell-mediated
cytotoxicity assay with
multiple assay formats
- Syngeneic mouse
model and humanized
immunity system model

39. Overview
BioDuro
Integrated Drug Discovery at BioDuro
The BioDuro Advantage
All major discovery functions in Shanghai for
single site execution
Enhanced program communication and
reduced cycle times
Seamless transfer of programs to San Diego
for formulation and IND study support
Reliable external partners ready to
supplement our core expertise
- Integrated with client
- Functions at one site
- Minimize cycle times
In vitro
DMPK;
in vivo PK
Program
Management
Formulation
Development
Analytical
Services
In Vivo
Pharmacology
Biology, Assay
Development
Medicinal
Chemistry
SBDD
Computational
Chemistry
Fragment
screening
X-ray
crystallography
GPCR
screening

40. Overview
BioDuro
SPF area: ~18,000 square feet
IVC system: 7,680 mice
AAALAC Accredited Animal Facility

41. Overview
BioDuro
CMC Capabilities Overview

42. Overview
BioDuro
Pre-Formulation
Physical, chemical and biological
characterization
Using drug attributes to predict the best formulation approach:
Aqueous solubility (pH dependent)
Solvent/oil solubility
Thermal stability
Polymer miscibility/interaction
Partitioning (logP, logD)
Particle size
Excipient compatibility

43. Overview
BioDuro
Overview
BioDuro
Formulation Development
Formulation Solution Engine
Drug characteristics drive development choices
Custom solutions platform enables rapid development
Understanding Delivery Needs
Improving solubility, maximizing stability, engineering rate and location of drug
release
Full use of technologies such as Spray Dried Dispersion, Hot Melt Extrusion,
Coating, Matrix tablets, etc.
Lead prototype identification, scale-up and technology transfer to manufacturing,
overseen by formulations scientists

44. Overview
BioDuro
Examples of Recent
Formulations Developed
Patent Application for Oral
Protein Delivery Filed
Patent Application for
Gastroretentive
Formulation Filed
Formulation Development: Key Experience
- Standard oral formulations
- Amorphous dispersion
based formulations
(SDD/HME)
- Controlled release dosage
forms
- Coated
tablets/capsules/particulates
- Matrix/gelling tablets
- Dissolution controlled
particulates
- Topical formulations
- Oral protein formulations
- High activity retention after
processing
- Protection from denaturing
conditions
- High activity density

45. Overview
BioDuro
Solubility Enhancement Techniques
Amorphous Dispersion Feasibility
• <.05 g of API
• MicroEvap Processing- PreClinical Solubilization
• Small samples for Discovery/Early Development
• Screen Excipients for SDD, HME
Amorphous Dispersion Development/Scale-Up
• 5+ g of API, 100g-500g Dispersion
• HME (Leistritz Nano 16mm or ZSE
18mm)
• SDD (Anhydro MS-35 and MS-150)
API Availability
Discovery (Selection), Early Tox, Early Preclinical
Candidate
• 0.5-5 g of API, 2g-10g of Dispersion
• MiniExtrusion with Haake MiniCompounder
• MiniSDD with Buchi Nano B90, B290 Spray
Dryer

46. Overview
BioDuro
Data-Driven Drug Development : The BioDuro Advantage
Solutions
• Melting Point
• Crystallinity
• Solubility
• Aqueous
• Micelles
• Solvent
• Solvent Stability
• Thermal Stability
• Powder Flow
• Max. Absorbable Dose
• Max. Tolerated Dose
• Permeability/Efflux
• Absorption Window
• Relative Bioavailability
• Pharmacokinetics
• Dose Format
• Tablet/Capsule/Other
• Solubilization Approach
• Nanosuspension
• Amorphous API
• Solution
• Controlled Release Approach
• Enteric Coating/Matrix
• Matrix Disso Rate
• Release Profile (Cmax,Tmax)
• Dose Limits
• Bolus Delivery/Permeability
Enhancement
Final Dosage Form
Pre-FormulationData
Chemical/PhysicalBiological
ISSUES
• Dosage Form for Best
Compliance
• Solubility Limits BA
• Stability in GI Tract
• Narrow Therapeutic Window
• GI Regional Absorption
• Poor Permeability

47. Overview
BioDuro
Analytical expertise that drives sound formulation and process
development decisions
Analytical methods developed
compatible with formulation
properties
Analytical Chemistry
Timely release testing of
manufactured clinical trial material
Seamless transfer of robust
methods, and validated in phase-
appropriate manner
ICH compliant stability
monitoring to ensure product
quality
Flexible teams supporting stand-
alone, and fully integrated projects

48. Overview
BioDuro
- Provides analytical support through continuum of
services for discovery and development
- Purification
- Compound Characterization
- Process Scale Up
- cGMP Manufacturing
- Release and Stability Testing
- Key Analytical Equipment
- LC-MS (Agilent, Shimadzu)
- HPLC/UPLC (Agilent, Shimadzu, Waters) including Prep-
HPLCs and Chiral HPLC
- SFC (Waters Thar)
- GC-MS (Shimadzu) and GC (Agilent)
- NMR (2 Varian, 2 Bruker)
Global Analytical Chemistry Capabilities

49. Overview
BioDuro
Analytical Chemistry
The BioDuro Advantage
Close integration with formulation
development, process development
and manufacturing teams for
coordinated and timely analytical
support throughout the entire
program.
Analytical Development
Method evaluation
Method optimization
Method transfer
Method development
Phase-appropriate method validation
Stability/QC testing
Release testing of raw materials
Release and stability testing of drug product/CTM
In-process testing during manufacturing
Stability program management, testing and storage
Cleaning verification

50. Overview
BioDuro
cGMP Manufacturing
High quality clinical trial material
manufacture through Phase III
Dosage Forms
Tablets
Capsules
Beads, Pellets and Granules
Oral Liquids
Topicals
API in a capsule (Xcelodose®)
Final Product Packaging and Labeling
CTM Storage and DistributionHot Melt Extrusion
Spray Dried Dispersion
Roller Compaction
Pan Coating and Wurster Coating
Granulation (wet, dry, high shear)
Fluid Bed Drying
Milling Blending, Compression
Encapsulation
Process Technologies
Packaging, Labeling, Distribution

51. cGMP Manufacturing
The BioDuro Advantage
Seamless transfer of formulation
knowledge from development to scale-up
to GMP manufacturing
Flexible and reliable manufacturing
operations designed to customize
production according to client needs
Transparency and open communication
with clients during manufacturing
Engage at process development or directly to GMP manufacturing
Scalable and mobile equipment for 9 manufacturing suites
Formulation scientists in the suites during production
In suite process observation by clients
Real time status updates from technical/project lead
Compliance oversight by experienced QA auditors

52. Overview
BioDuro
Project Management Quality Assurance
Supporting Functions
Drive project initiation process
Define and monitor project timelines
Provide weekly or biweekly project updates
Management of project scope and budget
One primary communication contact
Coordination of activities
Risk management
Conflict resolution and escalation of issues
Review of cGMP documentation
Employee training
Conduct internal audits
Hosting regulatory and client audits
Vendor management programs
Creation, review and approval of SOPs
Change control management
Quality metrics

53. Overview
BioDuro
Integrated Drug Development at BioDuro
All functions in San Diego for single site
execution
Product and process development know-
how maintained at single CRO
Seamless and efficient transfer from pre-
formulation to CTM manufacturing, from
preclinical through to Phase 3
- Integrated with client
- Integrated internally
within teams
Program
Management
Pre-
formulation
Formulation
Development
Analytical
Development
Engineering
batch
manufacturing
cGMP CTM
manufacturing
Release and
stability
testing
Packaging and
Distribution
The BioDuro Advantage

54. Experienced and Client Focused
Broad range of scientific backgrounds
Scientists as project leads providing real time 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

55. San Diego USA Beijing China Shanghai China
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