Reliable and
Flexible Partner

Samsung Biologics offers advanced cGMP facilities providing safe and reliable clinical and commercial biologics. All processes are cGMP-compliant and meet the standards defined by regulatory authorities. Our dedication to quality and optimized services are visible in everything we do from clinical to commercial production.

Mammalian Cell Culture

Large Scale

As the world’s largest CDMO by production capacity, we can offer the large-scale commercial manufacturing of drug substance in multiple scales and capacity. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A bulk filling capacity, as well as product pool vessel capacities from 200 liters to 15,000 liters to handle a wide range of pool volumes.

Small Scale

Equipped with a wide range of bioreactor sizes as well as new manufacturing technology, we offer multiple cGMP manufacturing facilities to deliver the production volumes required by our clients at any given time. Our small-scale manufacturing facility has the same best-in-class characteristics and equipment as our large-scale plants, featuring stainless steel and single-use bioreactors at 1,000 liter scale, and one purification suite with pre- and post-viral segregation.

Multiples Scales, Multiple Capacities,
to fit various processes for any production volume

sCMO4,000L
1K x2 Single-use , 1K x2 Stainless steel 1K x2 Single-use , 1K x2 Stainless steel
Plant 130,000L
5K x6 Stainless steel 5K x6 Stainless steel
Plant 2150,000L
15K x10 Stainless steel 15K x10 Stainless steel
Plant 3180,000L
15K x12 1* Stainless steel 15K x12 1* Stainless steel
  • 1 * Plant 3 has Fed-batch with N-1 Perfusion Capability

mRNA Vaccines

Overview

Unlike mammalian drug substance manufacturing which requires prolonged periods of cell culturing, mRNA drug substance production is a cell-free process that involves linearization of plasmid DNA(pDNA), mixing it with enzymes and nucleotides to allow for its transcription into mRNA, and mRNA capping, etc.
※ Samsung Biologics will add mRNA vaccine DS production capability to its existing facility by the first half of 2022.

Manufacturing
Process

mRNA vaccine production begins with in-vitro transcription, where the linearized pDNA is synthesized to form mRNA in a reactor. Then, the mRNA is purified in steps involving chromatography and ultrafiltration(UF)/diafiltration(DF) to prepare for the formulation stage. Finally, the purified mRNA is encapsulated into Lipid Nanoparticles (LNP) through precise pump mixing technology to prevent degradation and to allow for in vivo delivery.

Storage

Because mRNA vaccines are susceptible to degradation upon changing temperatures, it is subject to strict storage conditions. Samsung Biologics is able to meet such challenges though its upright and walk-in storage systems with temperature as low as -70°C as needed.

How mRNA vaccines are made

How mRNA vaccines are made image
How mRNA vaccines are made image

Why Samsung Biologics?

As the global biologics market gets more competitive, clients' needs and market uncertainty is growing more than ever before. Samsung Biologics promises that your invaluable molecule will be delivered to the market safely and quickly. Whether you are looking for standalone services or a seamless, integrated manufacturing service from clinical to commercial, we are focused on providing an unsurpassed level of customer service dedicated to the needs of our individual customers. We believe and are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions and proven expertise.

Fully Integrated
One Stop Service
Offering services from clinical to commercial manufacturing with dedicated QC lab and RA support
Modernized State
of the Art Facility
Newly built facilities fully compliant with cGMP that guarantee you the best environment for your product
Prompt
Responsiveness
We value your time and
promise a prompt response
Flexibility from
1K to 15K
With various different scales, we have a solution for you

SITE MAP

close
Close

Your download is ready

Click Download.

Close

Subscribe to Our Newsletter

Please fill in your details, select one or more areas of interest, and click the subscribe button to receive our newsletter.

Subscribe to Our Newsletter
  • Privacy Policy to collect the email address that I have provided until I withdraw my consent. The collected information will only be used for the purpose of mailing service. If you do not wish to consent, you will not be able to receive the newsletter. Samsung Biologics respects the privacy of its subscribers.
Close

Please fill out the form
to view the full content

Please sign up to view the post..
* Required
Privacy Policy
close

SECURITY REPORT

Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.

  • This page is created for reporting core technology and management information leakage.
  • The reported contents as well as the identity of the reporter are strictly secured.
THE MANUAL FOR SECURITY NOTIFICATION