The Power of One
Samsung Biologics is driven to help create quality biomedicines that
enrich life. We believe continued efforts to update current technology to the highest standards of safety and potency are essential to achieving this goal.
Our on-site Bio R&D Lab also offers up-to-date and technologically innovative sources of mRNA-LNP, enabling advanced manufacturing capability that is always ready for on-time customer satisfaction.
Custom mRNA Services
With highest-level compliance and a dedicated team of mRNA experts, Samsung Biologics accommodates your needs by providing customized services for any scale-up study in mRNA and lipid nanoparticle (LNP) production.
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- Scope
- mRNA / saRNA / circRNA
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- IVT* Batch Capacity
- 0.1 L to 200 L Single-use
*In vitro transcription
Agile mRNA Development Services
With our fully integrated solutions for mRNA GMP manufacturing that span process/method development, process/product characterization, and analytical testing, we help steer your innovative therapeutic through clinical and commercial stages.
- Process
- mRNA / LNP Process Development
- Non GMP mRNA / LNP DS
- Analytics
- Method Development / Qualification
- Method Transfer to QC
CGMP mRNA / LNP DS
Seamless CDMO Tech Transfer
Flexible scale-up precisely tailored to your needs
In the rapidly evolving mRNA industry where early-phase materials dominate, agile and swift small-scale production for clinical studies is essential. Samsung Biologics is ready for both current and future demands, offering seamless tech transfer with flexible scale-up from lab to commercial levels tailored to your needs.
One-stop mRNA Manufacturing Services
From pDNA linearization to fill & finish, Samsung Biologics uses flexible solutions and proven expertise to commit to an on-time, in-full delivery of mRNA vaccines and therapeutics we manufacture.
- pDNA- Linearization
- mRNA Synthesis IVT C/T
- mRNA Purification(UFDF, Chromatography)
- LNP Formulation
- LNP Purification (TFF)
- Aseptic mRNA filling
- Labeling & Packaging
- Automated Warehouse
In-house Bioanalytical Services for GMP
Our customized quality control services for mRNA in vitro transcription (IVT), LNP, and fill-finish are conducted fully in-house, enabling swift release without undue delays.
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IPC* Testing
*In-process control
- • Physical chemistry-based assays
- • Mass-based assays
- • Plate reader-based assays
- • Cell-based assays
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- Release Testing
- • In-process control
- • Compendial testing
- • Microbial identification
- • Sterility testing
- • CCIT/Extractable volume
- • Particulate testing
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- Biosafety Testing
- • Bioburden testing
- • Endotoxin detection and quantitation
*In-process control
Innovative Scientific Support
Proprietary sequence design features ranging from untranslated regions to unique poly(A) tail structures provide both contract research service and research collaboration opportunities. Tackling complex synthesis and purification processes can be customized for project-specific requirements.
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- mRNA sequence design
- • AI-based optimal sequence design algorithm platform with in-silico and in vitro validation
- • Customized mRNA sequence design service with improved protein expression profile and mRNA stability
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- Poly(A) tail shield
- • Proprietary mRNA tail sequence and structure with manufacturing advantages
- • Recombination-resistant design and QC-friendly homopolymeric characteristics
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- circular RNA (circRNA)
- • Manufacturing platform for novel forms of RNA structure
- • High circularization efficiency and purification of biologically active fractions
