Yaohai BioPharma

About Us
◆ Founded in 2010, located in China Medical City
◆ The 1st and Largest microbial CRDMO, end-to-end solution provider in China
◆ 500 team members

Services:
◆ Focus on recombinant proteins, peptides/polypeptides, enzymes, antibody
fragments and single-domain antibodies (sdAbs), plasmid DNA and mRNA,
China Medical City
glyco-polymers, virus-like particles (VLPs)
◆ Meet global customers’ clinical and commercial needs in biological drugs,
biosimilars, vaccines and diagnostics for human and animal health, aesthetic
medicine

Advantages :
◆cGMP Production Platform 7500+L
◆The Largest GMP-level Plasmid Supplier in China
◆Explosion-proof Facilities (High Potency Manufacturing Suite)
◆Bio-safety Level 2 (BSL-2) Lab for CDO
◆Allowing Customer PM/Technical Personnel to Be Stationed On-site
Global Market
CDMO Market Growth Rate by Region (2022-2027)
Source: Mordor Intelligence

Global CDMO Market By Cell Line Type $Million (2022)

>50% Source: www.psmarketresearch.com

20-30%
 Position In The Industry
The First and Largest CRDMO in Microbial Expression System
Revenue in 5 years
in China. (USD, million)

11.1

1 1 CAGR89%

7.63

3.89
3.20

Top 1 Top 1
Number of Scale of 1.04

serviced projects production capacity

(7500+L） 2017 2018 2019 2020 2021
Facilities
G29
10, 000 m², in Production
DS Workshop III：50-100L, DS Workshop IV：50-500L,
DS Workshop V：50-200-500-2000L,
DP Workshop II, Quality Control Center

G27
8, 000 m², in Production
DS Workshop I：50-500L, DS Workshop II：50-200-1000-2000L
DP Workshop I

FDA/EU Industrialization
Beijing Branch Standard
Process Development Center
Nucleic Acid Drugs and Single-domain Antibodies CRO/CDO
Quality Research Service
 Technical Capabilities
Yaohai Bio-Pharma (Yaohai) concentrates on three principal technology areas: recombinant proteins, nucleic acid drugs and single-domain
antibodies. Yaohai assists global biotech and pharmaceutical companies with all processes from R&D to commercial production, such as strain
construction, analytical method development, process development, stability research, IND production for Phase I-III, registration & application,
commercial manufacturing to serve customers with solutions for the whole process from Pre-IND to commercial production. Yaohai is engaged in
providing efficient and feasible CDMO services and solutions to customers and facilitate the R&D of new drugs.

Recombinant Protein Nucleic Acid Drug Single-domain Antibody

(sdAb)
End-to-end CDMO service platform for Focusing on the use of plasmid and mRNA,
Global expression platform
recombinant protein/polypeptide drugs accelerating the progress
from R&D to clinical application
Well experienced and equipped with LNP
 Expression Systems

E. coli Yeast Tailor Constructed Strains

K-12 strains & derivatives (DH1, DH5α, Pichia pastoris, Hansenula polymorpha, Other microbe/microbiota/microbiome
RV308, W3110, MG1655, JM109, BW25113…) Saccharomyces cerevisiae, etc. provided by customers, such as customized
B strains (BL21, BL21(DE3), BL21(DE3) protease-deficient engineered bacteria
pLysS, BL21(DE3) Rosetta…)

Yaohai has an integrated service platform from R&R to cGMP manufacturing to produce recombinant proteins, plasmids, and
antibody fragments with expression systems of E.coli, yeast and customer-supplied or in-house engineered microbial strains.
 Service System
ONE-STOP
CRDMO

Quality
CRO CTO CDO CMO Management

Microbial Lab-scale
Selection of Analytical Strain Process Sample Commerci GMP
Nucleic Acid Process Quality Registration IND alized
Method Stability Engineerin Scale-up Production Quality Verific
Drugs & Single- Development Standard & Applic
domain Develop Research g and
&
&Optimiz
Research Application ation
in Phase Productio Manag ation
Antibodies ment Constructi ation I/II/III n ement
on Optimization

Microbial Strain
Process
Customized Engineering and Registration & Production in Commercial-
Development & IND Batches
R&D Services Construction/Strain Application Phase I~III ized Production
Optimization
Bank Construction
 Cooperated Projects
US-CN EU-CN AUS-CN CAN-CN
application application application application

7 1 2 1
Based on project phase Based on project type
Recombinant antibody
IND 7%
32% Recombinant peptide
3%
Vaccine
8%
Nanobodies
8% Recombinant
CircRNA protein
2% 55%

mRNA
Phase I 8%
Pre-IND 9%
53% DNA plasmid
9%
Phase II
4%

Phase III, 3% Recombinant protein DNA plasmid mRNA

CircRNA Nanobodies Vaccine
Recombinant peptide Recombinant antibody
 Core Services

Strain Construction & Process Development GMP Compliance Method Development &
Strain Bank Establishment & Optimization Scale-up Production Quality Control

➢ Strain construction ➢ Fermentation process ➢ Fermentation scale-up & ➢ Quality standards research
➢ GMP secondary strain library development & optimization production ➢ Method development & validation
(WCB+MCB) establishment ➢ Purification process ➢ Purification scale-up & ➢ Sample commissioned testing
development & optimization production ➢ Stability & compatibility
➢ Preparation process ➢ Preparation production research
development & optimization ➢ Preparation of standards
➢ Related product preparation
 Filling and Finishing

Specification Maximum
Workshop Equipment Dosage Form
Range Output

Filling speed:
1500m²Aseptic Pre-filled injectables
Annual production:
2ml vial 160~300 vials/min,
preparation workshop in Lyophilized powder injections
10ml vial 140~200 vials/min 10 million injection (vials)
accordance with GMP 1-25mL
Eye drops
Lyophilization capacity: 5 million lyophilized
requirements for Any
Oral solutions powder for injection (vials)
2ml 37800 vials (4200 * 9 layers)
Modalities (biologics,
10ml 20043 vials (2227 * 9 layers) Inhalation formulations
vaccines, chemicals…)
Equipment For Process Development

1 2 3
1 –Sartorius BIOSTAT C Full-
automatic Bioreactor-30L

2 –Quadruple Fermentation System

Made by Bioengineering AG -7L
3 – GE AKTA System

4 –BIO RAD Gel Imaging System

5 – qPCR Made by ThermoFisher

4 5 6 6 –SCIEX Capillary Electrophoresis;
 Equipment For Drug Substance

Fermentation system 00 L Automatic buffer

Disc centrifuge High pressure homogenizer
Configuration/storage system

Explosion-proof facilities/ RP system Sterility Isolator Hollow fiber system

 Equipment For QC

HPLC
Agilent 1260

Molecular
Devices iD3
HPLC
Thermo (U3000/Vanquish)

GC QPCR
Agilent 8890 ABI QuantStudio5
 Strategic Planning

CRDMO Integration

CDMO Aesthetic Medicine

◆ Extend service chain ◆ Based on the microbiology expression and cultivation

◆ Form CRO/CDMO integration ◆ Raw material and CDMO service integration
◆ Promote the comprehensive competitive ◆ Give full play to the comprehensive advantages of talent and
advantage of technology and scale microbial track
 Website: https://www.yaohai-bio.com.cn/
Email: [email protected]
Yaohai will live up to your trust！

SERVE WITH HEART, CREATE THE FUTURE TOGETHER