driven. for life

Driven. For Life.Trusted End-to-End CDMO Partner for Your Journey

samsungbiologics.com

Your Powerhouse for SuccessIn less than a decade, Samsung Biologics has gained the reputation as one of the most trusted CDMO partners with an impeccable global track record. 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.

Our modular expandable facility, located in South Korea's biopharmaceutical hub, is currently the world’s largest and most advanced for biologics development and manufacturing. We credit this success to our unwavering commitment: to deliver the highest quality biologics as promptly and safely as possible.

Plant 2 154,000 L

Plant 1 30,000 L

620KLTotal Capacity

Unprecedented growth since its foundation in 2011 (as of September, 2021)

Plant 3 180,000 L

Plant 4 256,000 LPartial GMP operation expected to start from Q4 2022 (10,000L Suite) and Q4 2023 (2,000L and 15,000L Suite)

Upon completion of Plant 4A quarter of total global CMO capacity in 2023

3,800+ 25+163+ 100+Highly trained workforce Exporting countries

worldwideAccumulated projects contracted

Regulatory approvals (FDA, EMA, PMDA, etc)

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 utmost speed and cost-effectiveness without the hassle of multiple contracts and vendor management.

Early StageDevelopment

Setting a Rapid Pace EarlyWhatever your vision for your biologic is, we are here to accelerate it. Our streamlined platform processes and high-performing in-house cell line enables us to take your gene to IND in 9 months.

Our Service Offerings: ■ Cell Line Development

■ MCB Banking and Characterization

■ Upstream Process Development

■ Downstream Process Development

■ Formulation Development

■ Analytical Method Development

■ Non-GMP DS & DP Production & Stability Study

■ CMC Preparation & IND Filing Support

A Truly Seamless End-to-End Solution

Expediting your molecule from early stage to commercialization

Clinical Manufacturing

Commercial Manufacturing

Reliability & ExperienceWith a strong track record, our team can help you navigate complex regulatory processes with confidence. We ensure reliable supply at each clinical development phase.

Delivering On-Time, In-FullOur multi-scale, cGMP-compliant facilities for DS and DP manufacturing ensure maximum flexibility and economies of scale. We facilitate a seamless scale-up from clinical to commercial manufacturing.

Our Service Offerings: ■ cGMP DS & DP Manufacturing for Clinical Phase I, II, III

■ Single-Use or Stainless Steel Production

■ cGMP DS & DP Stability Studies

■ FMEA – Risk Assessment

■ Process Characterization

■ Analytical Method Validation

■ Process Validation

■ Release Testing

■ Regulatory Filing Support (BLA)

Our Service Offerings: ■ Gap Assessment

■ Process Control Strategy/ Scale Down Model Study

■ Analytical Tech Transfer

■ Engineering Run

■ Process Performance Qualification

■ Release Testing

■ Labelling & Packaging with Serialization*

■ Stability Testing

■ Regulatory Filing Support

Development

Streamlined process with faster timeline Fast-track development is becoming inevitable for market success. Equally important is getting it done right – streamlining cell lines, processes and analytical methods minimizes the risk of expensive and disruptive redevelopment requirement. With Samsung Biologics, you’ll have a partner with the expertise and solutions to strike the right balance while quickly laying a solid foundation for future success.

Platform Technology

Accelerated Timelines

◼ Process Development Platform, S-Cellerate™

◼ Contract Development Timeline (high productivity and stability)

◼ Samsung Biologics’ Proprietary Cell Line, S-CHOice™

ManufacturingDevelopment Aseptic Fill/Finish Bioanalytical Testing

Cell Line Development

• High productivity with titer up to 7+g/L• Robust viability of over 90% through day 21

Upstream Process

• Quick media selection• Application of pre-defined operating parameters

Downstream Process

• 3-step purification : Capture, MMX, CEX• 5-step filter : Depth, Micro, Nano, UF/DF

Formulation Process

• Screening matrix for pH, buffer, and excipientoptimization without development

AnalyticalMethod

• Predefined set of methods for productcharacterization and release/stability testing

ProcessCharacterization*

• Scale-down model qualification• Establishment of process parameter ranges for

process control

CHO-K1 cell developed using GS knock-out system

Accelerated Timeline Optimized PerformanceGene to IND in 9 months Established platform process

to ensure high titer and yields

Flexible OptionsMultiple cell line options available

(Months)10 5 113 9 132 6 124 108 147

Precisely tailored and optimized process to clients’ request including complex molecule▶ Standard Timeline ▶ S-Cellerate™ Fast Timeline

From DNA to IND as fast as 9 months using established process

Regulatory Filing Support

Regulatory Filing Support

Cell Line Development cGMP DS/DPProcess Development, Tox. DS/DPS-Cellerate™ IND Filing

Cell Line Development Process Development Tox. DS/DP cGMP DS/DPStandard IND Filing

* For Phase 2/3 programs transitioning to BLA filing

Manufacturing

Multi-scale solutions enabling maximum flexibilityAt Samsung Biologics, we understand the need for flexibility to quickly respond to changes. We operate fully integrated modular facilities at a single site with the latest technologies across multiple scales. Our team of dedicated experts with in-depth knowledge empowers us to take on any project at any stage.Leverage our leading-edge facility with all the capacity and expertise you need with only a single contract.

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.

Flexible Facilities


Plant 1 Plant 3Plant 2

5K x 6 15K x 1215K x 10

1K x 2 (Stainless Steel)

1K x 2 (Single-Use)

15K x 12

10K x 6

2K x 8

30,000L 180,000L154,000L

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

Optimal Technology Transfer

Process Characterization*

Process Assessment,Facility Fit & Gap Analysis

Analytical Tech Transfer

Process Development /Optimization*

Verification /Validation Run

PPQ Batches and Commercialization

◼ Process Development & Manufacturing Tech Transfer

◼ Extensive Equipment Capabilities

• Akta Avant 150• Akta Pilot • Sartoflow UFDF• Sartoflow Study UFDF• Up to 10 cm columns

DOWNSTREAMUPSTREAM• Ambr250• 10L bioreactors• 200L bioreactor

ANALYTICAL• HPLC• UPLC• ELISA

• qPCR• CE-SDS• SoloVPE

Plant 4(To be operational by `22-`23)

256,000L

End-to-End Offering Expert Team Seamless one-stop service from a single site

A single dedicated core team to drive your projects to completion

Multi-scale ManufacturingFlexibility to meet your specific supply needs

* if requested / required

◼ Unmatched High Throughput & Flexibility

◼ Future Expansion

Formulation Lyophilization Cold Storage Quality Control• Stainless steel or single-use system

• Temperature controls

• Two 180ft2/16.7m2 GEA units• Automated load/unload system• Cycle development service

• Ambient, Cold (2 – 8°C)• Freezer (-20°C)• Freezer (-40°C)• Deep freezer (-70°C)

• In-process & release testing• Stability testing• Container closure integrity testing

Aseptic Filling Inspection Labeling & Packaging• Grade A• Open/active RABS• Vials/PFS/Cartridge (1mL - 100mL)

• Stainless steel or single-use option

• 100% IPC weight check

• Manual• Semi-automatic• Automatic

• Printing and labeling• Packaging• Serialization

2 additional Optima Lyo units with 150,000 vials for 10mL vial by early 2022 Additional vial, PFS, cartridge filling lines by 2022

• Batch Size: 5L – 1,500L• Lyophilization: Two 2 GEA Units (180ft2 /16.7m2 each)• Filling: 12,000 vph max speed (1mL – 100ml Vials)

Line 1 Line 2• Batch Size: 5L – 2,500L• Filling: 18,000 vph max speed (1mL – 100ml Vials)

Drug Product Service Tailored to Your Needs

Our Drug Product Capabilities

High Production Capacity Client-centric Service

Faster Batch Release Global Track Record

Wide range of flexible DP batch sizes from 5L to 2,500L, with capacity up to 720,000 vials per day (max. 30,000 vph)

Tailored solutions from clinical to commercialization

< 30 days batch release 32 product regulatory approvals in 23 countries

Aseptic Fill/Finish

High throughput filling with quality assuranceDP fill/finish is one of the most delicate and critical steps in biomanufacturing. At Samsung Biologics, we offer our clients the most up-to-date, yet flexible fill/finish service that ensures product stability and patient safety. Our dedicated DP MSAT team for technology transfer and production maintains a stellar track record for minimal batch rejections and on-time delivery. This is how we earned the reputation of providing unmatched throughput and faster batch release without compromising on product quality or safety.


Tailored solutions from clinical to commercialization

Bioanalytical Testing

Comprehensive, precise in-house analytical testing

Experienced global regulatory support

Accurate and timely analytical testing is integral to the development and manufacturing of safe and stable biopharmaceuticals. Our comprehensive analytical testing services are carried out fully in-house from a single central location. This translates to significant time and cost savings for our clients.

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

Regulatory Support

Our Testing Capabilities

Accelerating the regulatory review process

Strong track record with global regulatory agencies

Highly experienced experts to facilitate data collection and assist with regulatory filings

Providing data integrity with our certified Information Security Management System

Testing Scope • Raw Material• Environmental Monitoring

• In-Process Control• Release • Media Fill Studies

Stability Testing • Validated Stability Chambers • Real-time and accelerated • Normal and Stressed condition from -86℃ to 50℃

Container Closure Integrity Testing

In-Process & Release Testing

• Sterility• Microbial Identification• UV Absorbance• ELISA• Cell-based Potency• Bioburden

• Endotoxin• Western blots• HPLC/UPLC• CE-SDS• SoloVPE• Flow Cytometry

• BioAnalyzer• Real time PCR• SDS-PAGE• iCIEF• Compendial Assays

Biosafety Testing • Mycoplasma Testing • In vitro adventitious virus assay • MVM DNA Detection

IND filing support with Module 2.3 & 3 of CTD and Type V Drug Master File with FDA

Proven Know-how

Regulatory Affairs Team

ISO27001 Certification

Full In-house Capabilities at a Single SiteAll under one quality system


Real-time Client Access Expedited Product ReleaseClient portal for record tracking,

document approvals Faster decision making

Sydney

Paris

London

Nairobi

Kuala Lumpur

Hong Kong

Shanghai

Beijing

Taipei

Singapore

Tokyo

VancouverToronto

New York

Brasilia

Berlin

Bern

San Francisco

Incheon

Driven. For Life.

Behind every vial is a person in need

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.

Enterprise Quality Unified Information System (EQUIS)

Real-time, in-process quality control

Digitally optimized smart lab

High cell density continuous production, for both TTF and ATF systems, that reduces production time by as much as 30%.

Virtual client access system to enable remote real-time access to view and approve all necessary GMP quality records and documents

Monitoring and release testing performed at manufacturing line to maximize speed and responsiveness.

We’ve digitized our in-house lab for paperless, efficient data management practices to increase speed and reducethe the risk of human error.

Continuousperfusiontechnology

We are Samsung, Innovation is in our DNA

Samsung is known all over the world for ground-breaking technologies that transform how people live. Samsung Biologics engenders that same spirit of innovation – we are continuously pushing the boundaries to redefine biologics development and manufacturing. We are bringing in new technologies – emerging bioprocessing technology, automation, and digitalization – to improve productivity and efficiency, enable real-time monitoring, and ultimately cut down 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.

Sydney

Paris

London

Nairobi

Kuala Lumpur

Hong Kong

Shanghai

Beijing

Taipei

Singapore

Tokyo

VancouverToronto

New York

Brasilia

Berlin

Bern

San Francisco

Incheon

Digitally optimized smart lab

mRNAvaccine & therapy

We’ve digitized our in-house lab for paperless, efficient data management practices to increase speed and reduce the the risk of human error.

Providing end-to-end mRNAtechnology-based solutionsfrom bulk DS manufacturingto aseptic fill/finish.(DS mfg. ready by '22 Q1)

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

CEO | US based Biopharma

Reaching around the World

Our headquarters and expansive facility are located in Incheon, Korea, an international biocluster. From this base we provide more than 25 countries with stable supply via qualified cold chain. We also offer cell line development at our site in the San Francisco biocluster, with plans for future expansions.

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 are thrilled beyond measure that Samsung chose to partner with us.

©2021 Samsung Biologics. All rights reserved

Headquarters 300 Songdo Bio Way (daero)Yeonsugu, Incheon 21987 Republic of [email protected]

Samsung Biologics America

600 Gateway Blvd.South San Francisco, CA 94080United [email protected]

driven. for life

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