Driven. For Life.

Trusted End-to-End
CDMO Partner
 Your Powerhouse
for Success
As a trusted CDMO partner, Samsung Biologics is currently serving global clients as the largest
and most advanced biopharmaceutical hub for biologics development and manufacturing. In an
increasingly competitive environment, working with the right CDMO is vital for successful drug
lifecycle management. We now serve more than half of the world’s leading biopharmaceutical
companies, sharing their mission to expedite patient access to life-saving biologics. We credit
this success to our unwavering commitment: to deliver the highest quality biologics as promptly
and safely as possible.

Bispecific
Nanobody
antibody

Monoclonal Our mRNA

antibody
modalities

Antibody-drug Recombinants
conjugates
A strong foundation for continued growth (as of June 2024)

4,600+ 2,000+ 24+ 275+

Highly trained workforce Cumulative projects Exporting countries Regulatory approvals
worldwide (FDA, EMA, PMDA, etc.)

784 KL
Total capacity
BIO Campus I Plant 5*

604 KL + 180 KL
*Operational by April 2025

ADC Facility BIO Campus I

Up to 500 L 604,000 L

BIO Campus II
720,000 L
A Truly Seamless
End-to-End Solution
Consistently improving speed to market is a key strategic measure for Samsung Biologics.
We see increasing evidence linking commercial success to the timing of market entry.

We offer a fully integrated service at a single site – a seamless solution that ushers your
discovery from early development through clinical and commercial manufacturing. This
full-service offering enables our clients to bring their transformational biologics to market with
the utmost speed and cost-effectiveness without the hassle of multiple contracts and vendors.

Accelerating Late discovery/

your success from Development
development to
commercialization Agile and flexible services
Whatever your biologics’ type, we help accelerate
the timeline by making your program our priority.
Our streamlined development process, diverse technical
platforms, and our customized CMC solutions SelecTailor™
enable us to advance your gene to IND and beyond.

Our service offerings:

■ Developability assessment
■ Early material generation
■ Cell line development
■ MCB banking and characterization
■ Upstream process development
■ Downstream process development
■ Formulation development
■ Analytical method development
■ Non-GMP DS/DP production
■ Non-GMP stability study
■ CMC preparation & IND filing support
Clinical
Manufacturing
Reliability and experience
With our adaptable small-scale batches, we provide a
seamless transition into the clinical stage and a steady
supply for each phase. Our experienced team can help
you navigate the complex regulatory process based on
our proven track record of success.
Commercial
Manufacturing
Productivity and on-time delivery
Our multi-scale CGMP facilities for DS and DP
manufacturing maximize productivity to speed up your
product to market. We leverage a stable supply chain
and proximity at a single site to ensure on-time delivery
of your drug.

Our service offerings: Our service offerings:

■ Phase-appropriate CGMP DS manufacturing ■ Large-scale DS/DP manufacturing
■ Phase-appropriate CGMP DP manufacturing ■ Labeling and packaging
■ Single-use or stainless steel production ■ Gap assessment
■ FMEA risk assessment ■ Process control strategy/scale-down model study
■ Process characterization ■ Analytical tech transfer
■ Analytical method validation ■ Engineering run
■ Process validation ■ Process performance qualification
■ IPC and release testing ■ IPC and release testing
■ CGMP DS/DP stability studies ■ CGMP DS/DP stability studies
■ Regulatory filing support ■ Regulatory filing support
 Development

Flexible solutions
for every development phase
Every development journey is unique and complex, requiring a flexible approach to
navigate the path to success. To proactively serve your specific needs, Samsung
Biologics provides comprehensive knowledge of your molecules with a tailored
service, leveraging our diverse portfolio, proprietary platform technologies, and
customized CMC solutions, SelecTailor™.

Accelerated Timeline
From CLD to IND filing, we provide a 10-month timeline for mAb and a 12-month timeline for complex molecules.

Cell Line Process Non-GMP Analytical Method CGMP IND Filing

Development Development DS/DP Development DS/DP Support

SelecTailor™: Customized CMC Solutions

Complete your development journey within 10 months with fully optimized services tailored to your development stage and specific characteristics.

Accelerated Timeline Multifaceted Approach Productivity Improvement

Simplified Comprehensive Enhanced

IND Package IND Package CMC Package
Expedite timeline focused on IND Provide widened scopes of study to Replace cell line, process, and/or
Phase 1 by utilizing in-house platforms mitigate the risk of development formulation to improve key features

Platform Technologies

An asymmetric bispecific antibody platform A developability assessment platform A transient expression platform using our
allowing high yield and manufacturability by utilizing an in-house scoring system to select proprietary cell line, S-CHOice®, to generate
maximizing HC-LC pairing the right drug candidates high productivity and quality

High-performing CHO-K1-based cell line Glycan profile modulation platform providing An intensified cell culture platform that
development platform with titers up to 7 g/L an in-depth investigation into critical quality improves productivity by increasing an ICD
attributes and cell culture conditions of a main culture through N-1 perfusion

Tailored solutions Diverse portfolio Smooth transitions

The most desirable service A wide range of molecule types One-stop CDMO service with
customized to your specific including complex molecules and flexible clinical manufacturing
requirements and the ADCs facilities and capabilities
characteristics of your molecule
 Manufacturing

Multi-scale solutions
enabling maximum flexibility
At Samsung Biologics, we operate fully integrated modular facilities at a single site
equipped with the latest technologies across multiple scales from 1 KL to 15 KL to
serve our clients’ needs.

Our dedicated team of experts is fully committed to identifying and mitigating risks
at every stage of the tech transfer process. This ensures a seamless transition to
commercialization. With our high-quality services, fast delivery, and proven track
record, we guarantee the success of your project.

Flexible Facilities
Our biomanufacturing facility is not only the world’s largest but also extremely agile. It houses multi-scale DS suites with both single-use and
stainless steel production options.

Plant 1 Plant 2 Plant 3 Plant 4 Plant 5

30,000L 154,000L 180,000L 240,000L 180,000L*

5K x 6 15K x 10 15K x 12 15K x 12 15K x 12
1K x 2 (Stainless Steel) 10K x 6
1K x 2 (Single-Use)
* Operational by April 2025

Optimal Technology Transfer

We excel at onboarding projects at any stage. Transfer your project to Samsung Biologics with the confidence in knowing that our expert team
will keep your project moving forward on time.

Process development & manufacturing tech transfer

Technical Transfer CPV*

Kick off ER PPQ Regulatory Approval Commercial

Process Monitoring

* CPV : Continuous process verification

Extensive equipment capabilities

• Ambr® Avant 150

• Ambr® 250 • ÄKTA pilot™ • HPLC • qPCR
Upstream • 10L Bioreactors Downstream • Sartoflow® UFDF Analytical • UPLC • CE-SDS
• 200L Bioreactors • Sartoflow® Study UFDF • ELISA • SoloVPE®
• Up to 10cm columns

Strong track record Operational excellence Robust supply chain

275+ approvals from global regulatory Manufacturing experts with know- On-time delivery achieved through
authorities and proven quality verified how and experience accumulated strategic partnerships with GMP-level
through global inspections from producing 2,500+ DS batches vendors and suppliers ensuring
(FDA, EMA, PMDA, MSDS, etc.) agility and security for your product
 Aseptic fill/finish

High throughput filling

for global distribution
At Samsung Biologics, we provide cutting-edge fill/finish services for product stability
and patient safety. Our dedicated Drug Product MSAT team ensures timely delivery
and high batch success rate. With unmatched throughput and expedited batch
release, we prioritize product quality and safety. Utilize our robust supply chain
management system for cost-effective global distribution.

Drug Product Service Tailored to Your Needs

Unmatched high throughput and flexibility

Formulation Lyophilization Storage Quality Control

• Stainless steel or single-use
system
• Temperature controls
2 2
• Two 180 ft /16.7 m GEA units
• Two > 441 ft2/41 m2 Optima units
• Automated load/unload system
• Cycle development service
• Controlled room (15 to 25°C) • In-process & release testing
• Walk-in cold room (2 to 8°C) • Stability testing
• Freezer (-20 to -40°C) • Biosafety testing
• Deep freezer (-70°C) • Media fill

Aseptic Filling Inspection Labeling & Packaging

• Grade A • Manual • Printing and labeling
• Open/active RABS • Semi-automatic • Packaging
• Vials • Automatic • Serialization
(1 mL - 100 mL)
• Stainless steel or
single-use options
• 100% IPC weight check

Drug Product Capabilities

Line 1 Line 2 Line 3

Liquid & lyophilized vial Liquid & lyophilized vial Liquid vial

∙ Batch size: 5 L – 1,500 L ∙ Batch size: 5 L – 2,500 L ∙ Batch size: < 50 L

∙ Lyophilization: 2 GEA units ∙ Lyophilization: 2 Optima units ∙ Clinical / Liquid only
∙ Filling: 12,000 vph max speed ∙ Filling: 18,000 vph max speed ∙ Filling: 600 vials/hr at 10 R
(0.1 mL – 100 mL vials) (0.1 mL – 100 mL vials) (0.2 mL – 100 mL vials)

High production capacity Fast batch release Global distribution

Wide range of flexible DP batch Accelerated batch release Within close proximity to minimize
sizes with capacity up to 600,000 within 30 days utilizing in- logistical hurdles and cost for
vials per day house analytical capabilities global distribution

Our Testing Capabilities
Raw material In-process
control
In-process & release testing
Biosafety testing
Stability Study
Compliance with ICH guidelines
• Long-term condition
• Accelerated condition
• Stressed condition
Validated stability chambers with real-time monitoring and alarm system
• Deep freezer, freezer, refrigerator, stability chambers with humidity control
Real-time client access
A quality management system
provides test and record tracking
and document approvals
Bioanalytical testing
Comprehensive analytical
testing at a single site
From raw materials to manufacturing, Samsung Biologics offers full-scope, in-house
testing services covering every stage of your product’s life cycle. Our dedicated
MSAT, QC, and development laboratories streamline processes, minimizing costs and
accelerating time to market. Accessing results is effortless with our digitalized quality
management system, instilling transparency and confidence throughout your journey.
Release Stability Validation Environmental
study (Media fill, BI, EI) monitoring
• Compendial Test • CE-SDS Reduced • Endotoxin Test
• Protein Concentration • CE-SDS Non-reduced • Bioburden
• Titer • Residual Host Cell DNA with qPCQ • Sterility
• Size Exclusion Chromatography • Residual Host Cell Protein by ELISA • Microbial Identification
• N-glycan Profile • Residual Protein A by ELISA
• Identification Test (Peptide/iCIEF) • Potency with Binding ELISA
• Flow Cytometry • Bioassay
• Mycoplasma testing • In vitro adventitious virus assay • MVM DNA detection
Seamless testing service Proven quality
All-in-one testing capabilities that Expedited batch release timeline
can release your product at a single and high batch success rate
site
 mRNA service

From pDNA to vial,

one-stop mRNA manufacturing
Samsung Biologics offers end-to-end mRNA services, encompassing DS and DP
manufacturing supported by dedicated MSAT laboratories and in-house testing
services. Our integrated approach allows you to navigate seamlessly from pDNA
to vial within a single facility, minimizing the risks associated with contamination
and degradation. Our commitment to excellence is demonstrated by our efficient
processes, integrating cross-functional expertise with state-of-the-art facilities.

mRNA Manufacturing
Capabilities

Scope IVT/LNP capacity Additional capacity

Drug substance and drug product 0.1 L to 200 L single-use bioreactor Temperature controlled process,
manufacturing for mRNA and saRNA with 1,536 m2 clean room LNP formulation – T-mixer,
explosion proof room

Process

pDNA- mRNA Synthesis Purification Encapsulation, Aseptic Labeling & Automated

Linearization IVT C/T (UFDF, Concentration) LNP Formation mRNA Filling Packaging Warehouse

mRNA Tech Transfer

Process Characterization
Technology Transfer Process Development Major Equipment
/ Process Validation

• Tech transfer for mRNA
drug substance
• Tech transfer for mRNA
bulk drug product
• Lab scale verification run
• Non-GMP analytical testing
• IVT study • Scale-down model • Ambr® 250
• LNP study development & qualification • Multi-vendor LNP mixers
• Chromatography resin/filter • PC master plan and reports • ÄKTA avant (25 & 150)
• Analytical method • Process validation master • Multi-vendor TFF system
development plan • Analytical devices for
mRNA & LNP

Dedicated MSAT lab In-house testing State-of-the-art facility

A fully equipped MSAT laboratory Expedited batch release with Flexible batch size optimized for
with experts providing integrated proven quality leveraging in-house the product with cutting-edge
solutions to facilitate your path to mRNA testing capabilities technology
success
 ADC service

Dedicated ADC facility

with dependable solutions
Using our operational excellence in antibody manufacturing and advanced scientific
know-how, we’ve established a standalone ADC facility to offer an innovative approach
to therapeutic development. Located across from our main manufacturing site, our
state-of-the-art ADC facility is supported by a robust supply chain system to ensure
high-quality product delivery and minimal risk.

ADC Development Service

Parallel development processes for antibody and conjugation

12
Cell Line Development mAb Process Development Non-GMP mAb Tox CGMP mAb DS

ADC Process Development Non-GMP ADC DS CGMP ADC DS Months

Process chart

Late discovery Conjugation Analysis Formulation

Toolbox options for optimal Method, parameter ADC method development Stability enhancement
developability selection optimization, and DAR and precise analysis/ and lyo development
variation control characterization

ADC Facility & Capabilities

Manufacturing workflow
• Up to 500 L conjugation train • HPAPI & cytotoxic handling facilities • Grade C & OEL target 5 ng/m3

Payload & mAb Prep Conjugation Formulated Bulk

mAb Payload Prep UF/DF 1 Reduction Conjugation Quenching UF/DF 2 Chromato- UF/DF 3 Formulation
Thawing graphy & Bulk Fill

Analytical testing
• QC testing mAb and ADC at one-single site with existing systems and procedures to expedite timeline
• Full-scope of laboratories for Development, QC, and MSAT

Strong background Integrated systems Proximity at a single site

Deep understanding of ADC Synergy with existing systems A successful product journey, agility,
characteristics and biological and procedures for both mAbs and security achieved by applying an
experience, with a proven track and ADCs to accelerate timeline existing supply chain
record of excellent quality
Global
Regulatory Affairs
Going the extra mile to take your product to success
Keeping up to date with current regulations is a challenge, especially in the rapidly evolving biopharmaceutical industry.
At Samsung Biologics, we are uniquely positioned to evolve and adapt to changes in the global regulatory landscape.
Our proven regulatory strategies for commercialization ensure success across product types and geographies.

Our dedicated regulatory affairs team works as an extension of your internal teams to provide all the necessary support,
from data collection to the completion of the technical portions of your filings to regulatory agencies worldwide.

Dedicated regulatory services from start to finish

Ensuring the quality, safety, and efficacy of your products from discovery to IND/CTAs, BLA/MAAs, and beyond

Regulatory
CMC Services

Agency
Meeting Support
Regulatory
Regulatory Strategy & Planning
Affairs
Services
GMP From Early
Evaluation Support Development to
Post-Approval Stage

IND/IMPDs & BLA/MMAs Support Real-Time Communication

Scientific and regulatory writing of CTA quality Providing clients with optimal regulatory pathways

Expertise in global compliance with a proven track record of success

275+
As of June 2024
30
FDA
32
EMA
213
Others

Since 2011, we have achieved an extensive track record with over 275+ product approvals from more than 46 regulatory agencies
worldwide, including the FDA, EMA, and PMDA. The wealth of experience proves our excellence in meeting global regulatory standards.
Greener Together.
Driven. For a Sustainable Life.
Your sustainable CDMO partner
Samsung Biologics is committed to achieving net-zero GHG emissions by 2050 and reducing the impact of our operations by
leveraging our environmental management strategy, including process energy optimization, transitioning to renewable energy,
and minimizing the use of disposables.

Commitment to Sustainability
As a member of the Sustainable Markets Initiative’s (SMI) Health Systems Taskforce since 2021, we
announced an open letter with CEOs of global companies and published the whitepaper “Decarbonizing
Healthcare Supply Chain” at COP27. We were the first CDMO to be awarded the SMI’s Terra Carta
Seal, recognized for driving innovation and actions to achieve a sustainable future.

To promote sustainable aviation fuel investment and reduce greenhouse gas emissions in logistics and
transportation, we joined the Sustainable Aviation Buyers Alliance (SABA).

We joined RE100 to achieve our goal of transitioning towards utilizing 100% renewable energy
sources by 2050. As part of this commitment, we aim to increase the percentage of power consumption
from renewable energy sources at our site’s operations from 30% to 100%.

Product Carbon Footprint

Site operations (Scope 1 & 2)
Identify annual reduction items to reduce carbon footprint

Supply chain (Scope 3)

Engage with suppliers to set a net-zero targets (with SBTi and RE100) and reduce the
carbon footprint from raw materials
We are Samsung,
Innovation is in our DNA
Samsung is known worldwide for ground-breaking technologies that transform how people
live. Samsung Biologics engenders that same spirit of innovation – we continuously push
the boundaries to redefine biologics development and manufacturing. We are introducing
new technologies – emerging bioprocessing technology, automation, and digitalization – to
improve productivity, and efficiency, enable real-time monitoring, and ultimately decrease
cost and time to market.

At the heart of everything we do is our deep desire and commitment to enable our clients to
accelerate life-saving treatments to patients in need.

Continuous Real-time Enterprise Quality Digitally optimized

perfusion
technology
High cell density continuous
production, for both TFF and
ATF systems, that reduces
production time by as much
as 30%.
in-process Unified Information smart lab
quality control System (EQUIS)
Monitoring and release Virtual client access system Digitalized our in-house lab
testing performed at to enable remote real-time for paperless, efficient data
the manufacturing line access to view and approve management practices to
to maximize speed and all necessary GMP quality increase speed and reduce
responsiveness. records and documents. the the risk of human error.

Driven. Behind every vial is a person in need

For Life.
Our vision for a better world through innovative science and
technology will only be achieved when the health and hope
within every vial reaches every person in need.
 Reaching around With our expansive facilities and qualified cold chains,
we provide a stable supply to more than 24 countries

the world from our headquarters in South Korea, the center of an

international biocluster. Additionally, our global presence
allows us to cater to your requirements in close proximity
to your location and time zone.

Incheon

Boston
San Francisco
New Jersey

Customer feedback
We are elated at the distinction of partnering with the world’s preeminent
biologics manufacturer for our franchise-defining drug. In the last four
years, Samsung Biologics has been among the most successful,
consistent and highest quality biologics manufacturers in the world. We
mRNA are thrilled beyond measure that Samsung chose to partner with us.

vaccine & therapy CEO | US-based Biopharma

Providing end-to-end mRNA
technology-based solutions
from bulk DS manufacturing
to aseptic fill/finish.
One of the decision-making aspects for this partnership was Samsung
Biologics’ dedication and commitment to providing high-quality services.
With this mutually beneficial partnership, we aim to further expand on
this development scope to bring innovative treatments for patients.
CEO | European Biopharma
Contact us

Headquarters New Jersey Office

300 Songdo Bio-daero 100 Challenger Rd.
Yeonsugu, Incheon 21987 Ridgefield Park, NJ 07660
Republic of Korea United States
+82-32-455-3114 sbio.us.bd@samsung.com
sbio.bd@samsung.com

San Francisco Office Boston Office

600 Gateway Blvd. 260 Franklin St.
South San Francisco, CA 94080 Boston, MA 02110
United States United States
sbio.us.bd@samsung.com sbio.us.bd@samsung.com

©2024 Samsung Biologics. All rights reserved samsungbiologics.com