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GenScript ProBio Introduction
Innovating Through Collaboration
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CONTENTS
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GenScript ProBio Introduction
Therapeutic Antibody
Gene and Cell Therapy
2016GenScript Group Introduction
Make Research Easier through innovative and
productive life science services and products
Life Science CRO
Make the best Biology products to improve the quality of
life and maintain a better nature environment
Industrial Synthetic Biology Products Innovative CAR-T technology to bring
miracle to bring
Cell Therapy
To accelerate drug development
through innovation and collaboration
GenScript ProBio
Innovative
Technologies
Drive
Sustainable
Growth
2
GenScript ProBio, A Leading Biologics CDMO
Global HeadquarterPiscataway, New Jersey, USA
Main Production SiteNanjing, China
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GenScript ProBio Established in 2019 Jan 1st
Providing end to end service
from discovery to commercialization
400+ employees
20+ experienced industry executives
The experienced project management team
with long track record
GenScript Biotech Founded in 2002
Publicly traded at Hong Kong Stock Exchange
(HKG:01548)
4000+ employees
No.1 in gene synthesis
Stringent IP protection
Key Messages from GenScript ProBio
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Proactive
Professional
Process
3 Key messages:
Proactive to customers
Providing professional solutions
Controllable quality processes
GenScript ProBio, dedicated to proactively provide end to end service (discovery to commercialization) with professional solutions and controllable quality processes to accelerate drug development for customers.
Our Vision and Mission
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Therapeutic Antibody
Gene and Cell Therapy
Your Most Reliable & Sustainable Biologics Partner
Innovating Through Collaboration！
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Continue To Improve Competitiveness with First Class Platforms
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GenScript ProBio Nanjing Bio R&Dcenter launched
July 2019
December 2019
1st January 2019GenScript ProBio officially established.
April 2019
Ground breaking ceremony for Zhenjiang commercial manufacturing center
Zhenjiang GMP virus facilityput into operation
2020
To be Continued…
Nanjing Bio MFG center Zhenjiang commercial manufacturing center
Senior Management Team
7400+ Staff, 200+ Master degree , 35+ PhD degree
Innovating through collaboration
Head of QualityFredy CHU
CEO of GenScript ProBioDr. Brian Hosung MIN
• 21 years plus experience on biologics development
• 11 years experience of antibody discovery in Amgen
• Led many projects on biosimilars as Vice President in Samsung Bioepisfrom 2008 to 2018
• 4 products marketed in US, EU and Korea, 2 entered clinical trial phase III, and 2 entered clinical phase I
• Over 10 years of experience in team management and business operation
• Over 14 years of experience in protein expression and biologics development
• 2 products entered clinical trials, 3 entered IND stage
Head of Operation Daniel WANG
Head of PM & RADr. Sean LIOUR
Head of GMPmanufacturingWeifeng ZHANG
Head of Global
Marketing & China BDLulu LIU
Head of R&DDr. Zhihui ZHAO
Head of Biologics DiscoveryDr. Liusong YIN
About GenScript ProBio
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GenScript ProBio is the bio-pharmaceutical CDMO segment of the world's leading biotech company GenScript Biotech Corporation (Stock Code: 1548.HK). GenScript ProBio is dedicated to proactively provide end to end service from discovery to commercialization with professional solutions and controllable quality processes to accelerate drug development for customers.
GenScript ProBio's innovative solutions for antibody drug development include antibody drug discovery (hybridoma, antibody library, fully human transgenic mice, bispecific antibodies technologies and single b cell screening technology), antibody engineering (antibody humanization, affinity maturation, Fc engineering) and antibody characterization( analytics and bioassays). In terms of biologics development service, GenScript ProBio has built the regulatory-compliant & integrated platform, from stable cell line development to clinical manufacturing services, providing high quality material for IND and clinical trials and accelerating drug development process. GenScript ProBio's gene and cell therapy solutions cover process development of plasmid and virus in IND filing as well as clinical manufacturing and commercial manufacturing. Our quality management systems ensure compliance, data integrity and traceability. With the principle of " Innovating through collaboration", GenScript ProBio is committed to shortening the timeline for biological drugs from discovery to manufacturing, significantly cutting down the R&D costs, accelerating the commercialization of medicines, and building a healthy future.
Therapeutic Antibody: From Target to Market
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Target discovery
Lead generation
Lead optimization
PreclinicalDevelopment
Clinical & Commercial Manufacture
• Target discovery • Target validation • Project planning and
development
• Hybridoma development, phage display, humanized transgenic mice
• SMAB Bispecific antibody• HTP screening & characterization
• Ab humanization • Ab affinity maturation• Developability assessment
• Stable cell line development• Process development • Analytical method development
and qualification • GMP scale up • PD/PK/Safety assessment
Streamlined Innovative Solution to Accelerate Drug Development Process
• cGMP compliant manufacture
(200L, 500L, 2000L)
Antibody Discovery Technologies
1010
Fully human Ab discovery
Anti-MTM Ab Discovery
SMAB Bispecific Antibody
FASEBA Ab screening
Humanized Ab discovery
• Matured hybridoma & antibody humanization platform
• Success rate as high as 95%
• Unique platform to overcome industrial challenge
• Boost the success rate to over 85%.
• Proprietary fully human naïve library and transgenic animal Ab discovery technology
• Reduce the risk of immunogenicity
• Patented technology
• Design concept of “Being Natural”
• High developabilityand CMC friendly
• HTP screening of
affinity, expression
level &
thermostability
simultaneously
Single B CellHigh
Throughout Screening
• Strategically collaborate with SCT
• Introduce in Berkeley Lights Beacon platform
• Completely preserve antibody diversity and increase the success rate of difficult projects.
-mTM: multi-transmembrane target
Fully Integrated Biologics Development Platform
1111
Cell Line development (CLD)
Process Development (PD)
Analytical Development (AD)
GMP Manufacturing (MFG)
Quality Assurance and Control
Regulatory Affairs (RA)
3.5 months from DNA to RCBAbout 25-people team; completed 80 projects
Compliance to GMP guidance in US, CN and EUCapacity: 50L, 200L, 500L
Phase-appropriate quality systemAbout 50-people team
9 months from DNA to toxicity materialAbout 90-people team; completed 30 PD projects
Compliance to all pre-IND analytical requirement About 40-people team; completed 20 IND-enabling AD projects
Consulting team of NMPA CDE reviewerSolid support for NMPA IND filing
Data updated in Nov. 2019
Biologics Development Service
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• Cell pool dev.• Cell line dev.
• Media & Feeding Selection
• Process development & optimization (Ambr-15, 3L)
• Scale up (10L& 50L)
• Purification process development & optimization
• Virus inactivation/ removal
• Formulation development
• Cell-based assay• Cell-free assay• LC-MS analysis• Physiochemical analysis
• DS manufacture (200L,500L, 2000L)
• Fill & finish
Stable Cell Line Dev.
Upstream Process Dev.
Downstream Process Dev.
Bioassay & Bioanalytics
GMP Scale-up
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•04/2018, Fu GAO: Strategic collaboration with
Fu Gao, Academician in Institute of Microbiology, Chinese Academy of science and TongYao Group •Collaboration on pre-clinical CMC and IND filing of immune checkpoint antibody drug.
•06/2018, Innovation Center for Immune Therapy of Tsinghua University•Signed Memorandum of strategic cooperation•Forming in-depth collaboration on antibody drug discovery, accelerating the commercialization of scientific research project.
•09/2018, Bliss Biopharmaceutical•Entered into a license and development agreement relating to a bispecific antibody (SMAB) product for cancer immunotherapy.•Granted the patent rights of the Product for exclusive use in the product development, registration and commercialization
•04/2019, REMD Biotherapeutics Inc.•Strategic Cooperation with REMD Biotherapeutics Inc. on bispecific antibodies(SMAB). •Granted REMD the usage of GenScript’s SMAB Platform to develop novel tumor immunotherapy drugs.
ADD-Strategic Collaborations
Proven Track Records
Lead Generation Lead Optimization CMC & Manufacture
440 Projects
210Projects
4IND
Approvals
*With 30 preclinical-CMC projects, 2 clinical manufacturing projects. **Anticipating 14 preclinical-CMC projects, 4 clinical manufacturing projects.
Accelerate drug discovery and development with High Integration and Unique Innovation
-By Dec. 31st 2019
32*
Projects18** more
in 2020
SMAB Platform
Hybridoma Platform
Library Platform
Single B Cell Platform
Nanjing GMP Facility for Preclinical Study-ADD
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Nanjing Facility
Capacity： 400L (2 x 200L)
Launch: Jul, 2019
• 5F: GMP manufacturing
• 4F: Cell line development & Process development
• 3F: Bio-analytics
• 2F: Antibody drug discovery
• 1F: Antibody drug discovery & Pharmacology
Total construction area: 8,640 m2
Nanjing GMP Facility for Clinical Production-ADD
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Nanjing cGMP facility for clinical production
• Designed by world’s top 3 pharma architecture firms• Compliant to GMP guidance in US, CN and EU• For Clinical I/II manufacturing• Total construction area: 7,650 m2
Capacity： 2,200L (6*200L; 2*500L)
Launch: Q4, 2020
• Production line Segregation
• Unidirectional flow for material, personnel, waste and cleaning
• Global standard clean utilities
• Disposable equipment
• Automated system
Blueprint: cGMP Facility for Commercial Production
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Commercial Manufacturing Center—2021Q1
• Compliant to GMP regulation in US, CN and EU
• For Clinical III and Commercial manufacturing
• Antibody Drug Dev. Capacity：• 5100L (phase I): 2x2000L, 1x500L and
3x200L• 9100L (phase II): 4x2000L, 1x500L and
3x200L
Quality Management System
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Vice president
QA
ValidationDocumentation
Control
Production QA Internal Audit
GMP TrainingRegulatory
Support
Quality SystemSupplier
Management
QC
Sample Analysis Stability Review
Analytical Method
Validation
Analysis EquipmentValidation
Environment Monitoring
Sampling, Specimen Retention
Vice president
Quality Management Structure Quality Management System
based on ICH and GMP, including 6 sub-systems
Quality Assessment
Quality Control
Production
Facility and Equipment
Material
Organization and Personnel
ICHGMP
Good quality culture from top manager to junior staff
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Excellent Market Performance
Over 10 IND Projects
Ongoing
Global Market Share in 2019
~50 Batches of
Manufacturing
Several Strategic Partners
Leading Position
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Experience Accumulation by Various Collaborations
• 2 IND clearance from NMPA: CAR-T and TCR-T;
• Over 10 CMC projects on going;
• Projects including CAR-T, TCR-T, UCAR-T, etc.;
• 3 US manufacturing orders;
• Collaboration with Merck to construct GCT platform;
• Collaboration with Genopis (US) on GMP plasmid mfg.;
• Capability and capacity expansion through construction of
commercial mfg. center.
Strategic Collaboration with various companies
Legend Biotech: World-class Innovation
Xlifescience Bioraylab
Merck Genopis
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GenScript CDMO Serving for Various GCT Products
Cell Therapy Process
Gene Therapy Process DNA Vaccine
Vaccination
Vaccine Gene
DNA vaccine
Expression Plasmid
• Preclinical plasmid Preparation• Plasmid Process Development
(IND filing)• Clinical Plasmid Manufacture• GMP Plasmid Manufacture
• Preclinical Virus Preparation• Virus Process Development
(IND filing)• Clinical Virus Manufacture• GMP Virus Manufacture
Gene Therapy
2 Helper Plasmids1 Target Plasmid
Gene encapsulated in AAV
• Preclinical plasmid Preparation• Plasmid Process Development
(IND filing) Clinical Plasmid Manufacture
• GMP Plasmid Manufacture
• Preclinical Virus Preparation• Virus Process Development
(IND filing)• Clinical Virus Manufacture• GMP Virus Manufacture
Cell Infusion
3 Helper Plasmids1 Transfer Plasmid
Effector Cells
Lentivirus with GOI
Cells from Patient
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GenScript Total Solution to Accelerate GCT Product Development
PreclinicalStage
IND Submission Clinical Trials CommercializationDiscovery &
Development
GCT Product Development Cycle
ProPlasmidmanufacturing
Plasmid/Virus Process Development
GMPro Plasmid Manufacturing
GMP Plasmid Manufacturing
Ge
nS
crip
t SE
RV
ICE
S
ProLentivirusmanufacturing
Antibody Screening
Gene Synthesis
Research Grade Plasmid & Virus
PK/PD Study
Clinical Protocol DesignGMP Virus
ManufacturingGMP Plasmid/Virus mfg.
GMPro Lentivirus Manufacturing
Currently available Partner Coming services
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Vector Platform Blueprint Covering Various Types of Vectors
Gene Therapy
Cell TherapyDNA Vaccine
Viral Vectors
Non-viral Vectors
Retro Adeno AAV HSV Lentivirus
DNA RNA EP
Mini Circle Plasmid DNA Physical
GGun Receptor Lipo
Chemical
Complexed Plasmid DNA
IVT-mRNA
Ready platform & platform in development
Platform in plan
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Service Competitiveness of GenScript GCT Vector Platform
Comprehensive Service
Service Competitiveness
Standardized Service
Professional Service
Serving for the whole development cycle Covering various vectors
Information confidentialityOne-to-one project management
Delivery with high qualityStandardized process, rapid turnaround time
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Facility Construction Plan for Consistent Support: from Early Research to Commercial
FA
CIL
ITY
2022 20232021 Q1
Lot Area：1,200m2
Accumulative Area：1,200m2Lot Area：2,500m2
Accumulative Area：3,700m2
Plasmid Process Development Facility
GMP Virus Facility
Lot Area：30,000m2
Accumulative Area：38,500m2
GMP Facility（Clinical and Commercial mfg. Center)
GMP Plasmid Facility
Lot Area：4,800m2
Accumulative Area：8,500m2
Building area: 130,000 m2
Capacity expansion Plasmid for early clinical phase
Preclinical plasmid preparation
Plasmid process development
Plasmid for early clinical phase
Preclinical virus preparation
Virus process development
Virus for early clinical phase
Plasmid and virus manufacturing for late clinical phase and Commercial use
AP
PL
ICA
TIO
N
2020Q2
Lot Area：6,354 m2
GMP Plasmid FacilityIn US
GMP plasmid manufacturing for clinical and commercial supply
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ZhenJiang Plasmid & Virus Facility
ZhenJiang Plasmid & Virus Facility
Virus Facility：2,500 m2
Plasmid Facility：1,200 m2
Plasmid CMC studyManufacturing for clinical phase I use
5L-100L stainless bio-fermenters
Virus CMC studyManufacturing for clinical phase I useCF10-CF40 Adherent production line
50L Suspension production line
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ZhenJiang Commercial Manufacturing Center
ZhenJiang Commercial Manufacturing Center
Lot Area: 30,000 m2
Capacity:
10—500 L single-use Bioreactors
10—200 L Suspension production line
CF10-CF40 Adherent production line
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Grand Opening Ceremony and Ground-breaking Ceremony of the Facilities
1st Plasmid Process Development Facility in China 1stGMP Biologics Commercial Center in China
Plasmid Process Development Facility in ZhenjiangGround-breaking Ceremony of GMP Biologics Commercial Center in Zhenjiang
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GenScript Quality Management System
ICH/
GMP
QA
QC
Production
Facility & Equipment
Material
Personnel & Organization
Facility & equipment maintenance
Production management
Testing & release
QA system
Warehouse managementMaterial management
Organizational managementStaff training
Quality system compliant to ICH GMP Quality Management System Structure
QA
Validation
Document Control
Production QA
Internal Audit
GMP Training
Compliance Support
Quality System
Supplier Management
QC
Sample Analysis
Stability Test
Analytical Method Validation
Instrument Qualification
Environmental Monitoring
Sampling, Retention
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Each Team Operating Independently, Providing Mutual Support
Production Team
Focus on the process development and manufacturing
of plasmid and virus
Quality Control Team
Focus on the analytics and quality control of the products
Regulatory Affairs Team
Keep abreast of new developments of regulations and
give recommendations
Quality Assurance Team
Dedicated to establishing quality management system
Independently operating, providing
mutual support
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Accumulation of Experience Market Position Experience Accumulation
Layout of Platform Facilities Platform Blueprint
Background of the Company Capital Experience Consistence Flexible Business Model
Introduction of Talents Professional Leadership Independent Department
Experience and Strength
Experience and Strength are Important Influencing Factors
